pharmaceutical resume samples for quality assurance

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The Quality Manager, also known as the Quality Assurance Manager, is in charge of overseeing the manufacturing process to ensure that all products meet uniform standards and business requirements. Their responsibilities include creating and implementing quality control tests, checking products at various stages, and preparing reports that detail production difficulties.

Resume of Quality Manager (Pharma) in Text Format

TANYA PRASAD

Phone: 9953776253 | Email: [email protected]| LinkedIn: linkedin.com/company/getsetresumes

QUALITY MANAGER - leveraging 12+ years of experience

Quality assurance executive with an industry experience of more than 12 years. Expert of national and international Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) regulations, guidance documents, and industry best practices. Methodical auditing skills with efficient risk identification methods. Well-ordered communication skills for coherently delivery of observations to both internal and external business partners and assisting in rectifying them.

PROFILE SUMMARY

• Designated ISO 13485 Management Representative ensures pertinent regulatory and customer requirements through the development, implementation, and refinement of quality plans and systems.
• Ability to effectively build and maintain relationships with multiple departments and external entities including Investigator sites, clinical Vendors and CROs in order to effectively solve problems.
• Proficiency in performing routine inspections and quality tests.
• Acquainted with the quality management cycle (i.e., PDCA), and corrective Action/Prevention Action (CAPA) processes.

CORE COMPETENCIES

• Quality Driven Management (QDM)
• Pharmaceutical Compliance
• Project Management
• Good Laboratory Practice
• Internal Auditing
• Good Manufacturing Practice (GMP)
• Product Lifecycle Management (PLM)
• Continuous Improvement Process (CIP)
• CAPA Quality Control
• Reporting and Documentation
• Quality Risk Assessment

PROFESSIONAL EXPERIENCE

Biotech Pharma, New Delhi Jan. 2017 – Present

Senior Director of Quality Management

• Lead and directs all quality assurance activities for the company.
• Oversee procedures for medical coding, internal data validation audits, clinical form development, and data and outcomes management for all contract programs.
• Administer Investigation and Deviation systems for tracking statuses, follow-up, and liaison with the applicable department, patient complaint management, IR/SE management and audit procedures to ensure timely resolution.
• Compile reports and identify trends or areas requiring additional actions.
• Develop strategic plans and policies for improved quality throughout the company and works with top management to ensure compliance with regulatory agencies. Support the activation of commercial sites and will perform quality risk assessments.
• Assist with completion of quality agreements; provide operational support for commercial site selection and activation of research and development laboratory centers.
• Manage interface with Quality Compliance audit team to support audit, due diligence, and inspection readiness plans.
• Administer internal audits and provides support for external inspections.
• Develop new and improved processes in collaboration with other QMS element Stewards and global leadership
• Provides quality systems support for all products including electromechanical, biomedical and medicines.
• Coordinate with plants, R&D, RA, and Labeling and other internal supervisors, functional peer and senior leaders and lead interactions with regulators and customers to represent the company products and processes.
• Identify and direct continuous improvement projects to achieve quality, reliability, and cost improvements.

Sun Pharmaceutical Industries Ltd., New Delhi | July. 2013 – Nov. 2016

Quality Manager

• Identified and drove continuous improvements to the product lifecycle management system while building and managing relationships with the National Business Units including R&D, regional supply chain, supplier quality management, post-market surveillance, marketing, and regulatory affairs to ensure alignment on strategic initiatives.
• Built new processes from scratch for production hurdles. Fostered trust within the team and helped create a better product for the customers.
• Served as one of the senior technical representatives in Product Development and Lifecycle Management (PDLM) in the Quality organization with responsibility for process results in terms of product quality, performance, and safety.
• Provided support for internal audits and external inspections.
• Developed new and improved processes in collaboration with other QMS element Stewards and global leadership. Influenced the decision-making process to ensure quality requirements.
• Includes all lifecycle phases from late-stage feasibility through development, sustaining, and discontinuation Served as the data architect for implementation of Product Lifecycle Management (PLM).
• Oversaw continuous improvement initiatives and actively complied with the company’s regulations.
• Participated as part of the Corporate Audit Team in both supplier and customer, regulatory, and internal audits.
• Provided quality and validation oversight including all facets of validation and development of quality control plan
• Reviewed designs and design changes, protocols, and document change requests.

Cipla Ltd., New Delhi | July. 2011 – Jun. 2013

• Supported the development, implementation, maintenance, and oversight of a clinical quality management system.
• Facilitated working groups to collaborate and write project-controlled documents as part of the quality management system: SOPs, Policies and Audit reports.
• Supported the development and implementation of the Clinical Quality Management System (Master Control).
• Stayed abreast with current GCP/GCLP regulations, including FDA, EU, and other regulatory bodies.
• Led audits of the various quality elements to ensure compliance to GCP/GCLP, industry best practices and guidance.
• Participated in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management.
• Supported the development and reviewed GCP/GCLP audit agendas, audit plans, audit reports, and CAPA's.
• Participated in preparations for regulatory inspections, including reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management of program inspection quality events.
• Review, track, and/or trends routine quality data Reported adverse trends to management with a remediation plan.
• Coordinated the development of various QA-related metric reports.
• Assisted in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and provide an assessment of the impact of any deficiencies.

ACADEMIC CREDENTIALS

Education – Master of Business Administration in Total Quality Management from Symbiosis University, Pune | 2011 B. Pharma from Jamia Hamdard University, Pune | 2008

Certification – Pharmaceutical Quality Manager from Institute of Good Manufacturing Practices in India | 2012

PERSONAL DOSSIER

Languages Known: English, & Hindi

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16 Quality Assurance Resume Examples - Here's What Works In 2024

If the tech industry were the publishing industry, quality assurance professionals would be the proofreaders. so much of our world runs on extensive lines of code these days, and it’s mathematically impossible for it all to be perfect. this article will show you how qa professionals are integral to the tech industry and give you resume examples to target these roles..

Quality Assurance professionals design automated code tests, identify software bugs, and help to fix the problems identified (or send them to the department that does). They also collaborate with other designers to create effective tests for new software and web applications. The user data collected in these tests is what allows the organization to make user-friendly, effective applications. As our world becomes ever more connected, even in the most mundane tasks like doing the laundry or turning on a light, the potential to collect this data and utilize it is everywhere. What this means is that the best QA professionals are both reactive and proactive. Entry-level jobs will likely deal mostly with legacy code, finding and fixing bugs. Growth from that position then has engineers creating automated tools to complete these jobs. However, the intermediate and higher skill-level QA professionals are both reactive and proactive. Knowing what questions to ask to avoid problems -- that is, effectively designing tests -- means working with multiple tech-industry teams, including UX/UI designers, software and web application designers, and, of course, the IT department. The path to this career involves the combination of critical thinking and good coding skills. Most professionals in this industry have a BA, and often they’ve completed specialized courses from either a university, a respected industry leader, or their corporations. Keep in mind that new technologies like machine learning will rapidly change this industry in the next few years, so that penchant for life-long learning and problem solving that led you to QA will serve you well in QA career longevity.

Quality Assurance Resume Templates

Jump to a template:

• Quality Assurance Tester
• QA (Quality Assurance) Automation Engineer
• QA (Quality Assurance) Engineer
• QA (Quality Assurance) Manager
• QA (Quality Assurance) Software Tester
• Entry Level QA (Quality Assurance) Tester
• QA (Quality Assurance) Analyst/Specialist
• Medical Quality Assurance Inspector

Jump to a resource:

• Keywords for Quality Assurance Resumes

Quality Assurance Resume Tips

• Action Verbs to Use
• Related Engineering Resumes

Get advice on each section of your resume:

Template 1 of 16: Quality Assurance Tester Resume Example

Many companies use quality assurance (QA) testing to ensure the products they create meet specific standards. Quality assurance testing allows companies to avoid sending out products to customers that are faulty or low-quality. Quality assurance testers can be found in almost every industry, from clothing to software. The quality assurance tester is responsible for performing a variety of tests on each product, constantly monitoring product performance, flagging issues, and troubleshooting them. When looking for a quality assurance tester, hiring managers will want a candidate with the right mix of experience and education. Typically, ideal candidates for the role will have a bachelor's degree in a related field such as computer science or analytics. They will want a candidate with related experience, such as prior roles as a quality analyst or test engineer. Additionally, it’s important that candidates for these roles demonstrate specific skills, such as knowledge of testing methodology, problem-solving abilities, and critical thinking skills.

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Tips to help you write your Quality Assurance Tester resume in 2024

   detail your experience utilizing different testing methodologies.

There are lots of testing methodologies that quality assurance professionals can use. Black box, user acceptance, and agile testing are just a few. Hiring managers will like to see an applicant who has experience with as many testing methods as possible. Showcasing what testing methods you are fluent in on your resume will show hiring managers that you are a dynamic and knowledgeable candidate.

   Showcase any certifications you have in quality assurance testing

You can earn certifications specific to quality assurance testing to showcase your knowledge in a concrete way on your resume. You can earn the ISTQB tester or analytics professional certificate to strengthen your resume.

Skills you can include on your Quality Assurance Tester resume

Template 2 of 16: quality assurance tester resume example.

Quality Assurance testers are the individuals and teams that run every test you can think of trying to see if a web application or software program will break. They have strong problem-solving skills, attention to detail, and excellent written communication skills. They’re the best at documentation and take the minute information and put it together in a system that the entire QA chain can understand.

   Related job experience is applied to current QA career path

Even if you choose to diversify your skill set by taking a position in a parallel career path (as this person did with the electrical project engineer role), it’s important that you highlight aspects of the role that apply to the QA job you’re seeking. If you’re applying for multiple roles in related industries, make sure you have a resume for each one with different highlighted achievements. Note how in this case we highlight achievements which are relevant to the quality assurance industry.

   Demonstrate impact with hard data in the QA field

As a QA tester, you’re going to need to demonstrate communication skills. The best way to do this is to measure the results or impact of actions you’ve taken, which this resume does by measuring the efficiency of tests when working with a team of software engineers. As a QA tester, you’re in an excellent position to measure the impact of your actions -- you are the one who tracks how many bugs are found after all!

Template 3 of 16: QA (Quality Assurance) Automation Engineer Resume Example

The quality assurance (QA) automation engineer plays an integral role in optimizing a company’s quality assurance procedures. These professionals plan and create automated tests to assess the function of software. Being able to automate the QA process allows companies to test their technology more quickly and efficiently, leading to increased revenue. To become a QA automation engineer, you will need the right education and skills. Hiring managers will look for someone with a degree in computer science or IT. It’s important that QA automation engineers are talented coders with a breadth of technical knowledge. Hiring managers will look for someone with experience in QA, such as previous roles as a manual tester or QA tester. Strong candidates for this role will have knowledge of different testing methods and coding, superb problem-solving skills, and organizational abilities.

Tips to help you write your QA (Quality Assurance) Automation Engineer resume in 2024

   highlight your knowledge of qa testing tools and frameworks.

To become a QA automation engineer, you will need to understand the variety of testing tools and frameworks you can use to solve QA testing issues. For this reason, you should highlight the testing methods and frameworks you have used in the past on your resume.

   Show your ability to creatively solve problems

QA automation engineers must be savvy problem solvers in order to create testing automations that are effective. As such, one important soft skill to highlight on your resume is your problem-solving skills. Be sure to highlight any complicated QA issues you have successfully solved in the past on your resume.

Skills you can include on your QA (Quality Assurance) Automation Engineer resume

Template 4 of 16: qa automation engineer resume example.

A QA automation engineer develops automated tests that are used to test the functionality of applications. They are tasked with designing the tests, creating the code for them, activating the tests, and reporting on how they perform. To succeed in this role, you will need to have very strong programming skills, as well as a wealth of experience as a QA automation engineer. Recruiters will be expecting at least a bachelor’s degree in computer science, software engineering, or a similar field.

Tips to help you write your QA Automation Engineer resume in 2024

   stay up to date with the latest development software and languages..

This is a very technical position that needs you to stay up to date with the latest software and software languages to stay relevant and useful. So make sure you stay up to date on the same. When any new relevant tech and software is developed, ensure you are quick to acquaint yourself with it. Do a course to learn the new tech or get as much experience with it as possible.

   Quantify your QA testing success.

Recruiters want to know how successful and efficient the tests you create and run are. So make sure you include actual numbers in your experience section. How many tests have you run in a short period of time? How many errors and bugs did your tests identify?

Skills you can include on your QA Automation Engineer resume

Template 5 of 16: qa (quality assurance) automation engineer resume example.

Quality Assurance Automation Engineers are the bigger-picture thinkers of the QA world. They excel at writing tests that can be iterated over large-scale and enterprise technologies, including databases. They know every aspect of the design of the program and how it should function. They often work on mobile and web applications. As with all QA professionals, they work with other engineers and developers, but they are also likely to have a team of QA testers who work with their code to identify particular bugs.

   Shows leadership amongst in-house and remote teams.

The larger-scale you get in technology, the more likely it is that you’re going to be working with distributed teams, even internationally. Your ability to communicate well with these teams on a technological and professional level is absolutely essential to the QA team working well.

   Cites specific automation tools in the QA space

As a QA automation engineer, you’re going to be approaching complex web and mobile applications as well as enterprise-level software. As a result, you want a wide coding toolbox to draw from. Demonstrating how your solutions work -- and that you have a diversity of hows at your disposal -- makes you an asset to your company.

Template 6 of 16: QA Engineer Resume Example

If you’re a technical whiz with great attention to detail, a position as a QA (quality assurance) engineer might be right for you. Before going to a customer, every product must be vetted and tested for quality. The QA engineer is responsible for giving each product the final check before it is shipped out. In order to ensure each product is flawless, QA engineers conduct continuous tests throughout the manufacturing cycle. The QA engineer must understand the larger picture, and work in accordance with the business needs and budget. To become a QA engineer, you will need a specific set of technical skills. You’ll need a bachelor’s degree in software engineering or another related field. Hiring managers will also look for a candidate who is proficient in a variety of testing methods. Previous experience as a quality inspector or tester can help you land this role. In addition to technical skills, it’s important that candidates for this role are detail-oriented with strong project management skills.

Tips to help you write your QA Engineer resume in 2024

   showcase your knowledge of testing methodologies.

QA engineers have to understand different quality assurance testing methods. Showcasing the testing methods you are knowledgeable in on your resume can help you land this role. You should put certain testing methodologies, like regression testing, in your skills section on your resume.

   Demonstrate your Scrum knowledge

Scrum is an agile project management framework that allows teams to manage projects through a set of specific principles. Having scrum knowledge as a QA engineer can help set you apart from the crowd and show hiring managers you understand how to organize projects in an effective manner.

Skills you can include on your QA Engineer resume

Template 7 of 16: qa (quality assurance) engineer resume example.

Quality Assurance Engineers are some of the generalists in the QA world. They’re often divided into manual and automated career paths, but in such an in-demand industry, the truth is that there’s more demand for QA engineers than there is supply. They work with software that already exists in the product market and with new and releasing products. They may also focus on internal processes of the company, not just customer-facing software.

Tips to help you write your QA (Quality Assurance) Engineer resume in 2024

   skills section reflects new trends in the qa industry and qa software.

As a QA engineer (or really any kind of engineer or developer), you’re going to be constantly on the forefront of new tools changing your industry. It’s important to note that you have the drive to continually learn these techniques when they become relevant and necessary to your job.

   Inclusion of the QA engineer title combats ATS (applicant tracking system) filters.

Anytime you’re applying for a specific role, you’ll get a higher ranking from ATS filters if you include the job title at the top of your resume as well as in specific job titles.

Skills you can include on your QA (Quality Assurance) Engineer resume

Template 8 of 16: qa (quality assurance) manager resume example.

As a QA (Quality Assurance) Manager, you'll be responsible for ensuring the quality and reliability of software or product releases. This role requires strong communication, analytical skills and attention to detail. With the recent shift towards automation and continuous integration and delivery, the value of a skilled QA manager has become more critical in today's industries. When writing your resume, be sure to highlight your technical expertise, adaptability, and strategic approach to problem-solving, as these are key aspects that companies are looking for in a QA manager candidate. In the ever-evolving tech landscape, it's essential to keep up with new tools and methodologies. For QA managers, this means staying current with industry standards and best practices in areas like test automation, performance testing, and security. Your resume should demonstrate your ability to learn and adapt to new technologies and processes, as well as showcase your track record of successful QA projects and process improvements.

Tips to help you write your QA (Quality Assurance) Manager resume in 2024

   highlight relevant certifications.

As a QA manager, having certifications such as ISTQB, CSTE, or CSQA, can be a significant advantage to set you apart from other candidates. Include any relevant certifications in your resume to showcase your dedication to the field and your expertise in various quality assurance methodologies.

   Demonstrate leadership and teamwork skills

As a QA manager, you'll need to work closely with cross-functional teams and lead the quality assurance team towards success. Your resume should showcase your leadership and teamwork abilities, including examples of how you've managed and motivated teams to achieve their goals and drive process improvements.

Skills you can include on your QA (Quality Assurance) Manager resume

Template 9 of 16: qa (quality assurance) manager resume example.

A Quality Assurance manager is a high-level employee who has experience as a QA engineer and tester. Their job is to understand how to best employ QA techniques and teams across the entire system. In other words, they create the strategy for effective testing so that no product hits the market without being thoroughly vetted.

   Emphasizes educational achievement combined with work experience in QA.

If you’re an advanced degree holder, you’re doing yourself a disservice if you simply list it without fanfare. You certainly should include any awards received as well as their rarity, particularly if they’re in a technical field (e.g. QA). If possible, you should include work achievements that you were commended that show your leadership experience, which is critical to being a manager. It shows that you can handle balancing your priorities and still excel.

   Highlights adaptability in industry by citing different project management/workflow strategies.

As a manager, you’re expected to be flexible enough to adapt to different teams but experienced enough to have definite opinions about how to help that team succeed. This resume shows that the application worked in Agile, waterfall, and iterative methods of software development, which covers the essentials of how any software team would work in the industry.

Template 10 of 16: QA (Quality Assurance) Software Tester Resume Example

Quality assurance is an important factor in the production process in many industries, particularly in software. QA (quality assurance) software testers help companies ensure their software is functioning correctly and effectively, before putting it in the hands of customers. QA software testers are responsible for assessing software, running various tests, identifying and solving bugs, generating result reports, and more. To become a QA software tester, you will need a degree in computer science or IT. Hiring managers will look for someone with previous technical and/or software experience, such as previous roles as a functional tester or application engineer. The ideal candidate for this role will have technical expertise, in addition to strong problem-solving and critical-thinking skills.

Tips to help you write your QA (Quality Assurance) Software Tester resume in 2024

   detail your experience identifying and solving bugs.

A big piece of the QA software tester’s job is to find and solve for bugs or issues found within the software. For this reason, you should highlight any experience you have identifying and/or solving for bugs in software. Even if your experience was in a different position, the ability to troubleshoot and problem solve is crucial to landing this role.

   Showcase your ability to make suggestions to stakeholders

As a QA software tester, in addition to testing for issues, you will have the opportunity to create ideas about how to improve or add integrations to existing software. If you can bring valuable insight to the role, companies will be more likely to hire you. For this reason, you should highlight any experience you have making improvement recommendations to stakeholders and leadership teams.

Skills you can include on your QA (Quality Assurance) Software Tester resume

Template 11 of 16: qa (quality assurance) software tester resume example.

Traditionally, Quality Assurance Testers come in at the end of the development cycle of a new product. The title QA software tester is often used to emphasize that the QA team is a part of the development of the product from start to finish. This means that the team works in an iterative and integrative way, and that QA software testers will pay attention to all things that will affect the function of the program, from bugs, to slow load times, to poorly written customer copy.

   Clear skills section to highlight QA testing skills to help with ATS (applicant tracking system) filters.

Especially in any tech field, your skills section tells a story. It shows the tools you have used and those you can bring to bear on the problems at hand. This is also an easy way to customize your resume to better fit a company’s needs -- if you have the tech skills they’re asking for, change them to match what’s in the job description and you’ll read as a better fit to ATS filters.

   Promotions within an organization show strong leadership skills and an employee that exceeds expectations.

Whenever you’re a person in a senior position with management responsibilities, one of the best things you can do is show when you were rewarded ahead of schedule or exceeded expectations. Any position, especially as a QA tester, is looking for strong soft skills and ability to lead — being promoted within 18 months of receiving a new position is a great example.

Template 12 of 16: Entry Level QA (Quality Assurance) Tester Resume Example

As an entry-level QA tester, you'll be starting your journey in the fascinating world of software quality assurance, ensuring that products meet the necessary standards for functionality and user experience. In this position, staying informed on industry practices and tools is crucial to staying relevant and developing your skills. As you write your resume, showcase your understanding of key testing methodologies and emphasize your passion for learning and improvement. In recent years, there's been a shift towards automation and data-driven testing processes. Companies are increasingly looking for candidates who can leverage these technologies to improve testing efficiency. Therefore, highlighting any experience or knowledge you have in these areas will make your resume stand out.

Tips to help you write your Entry Level QA (Quality Assurance) Tester resume in 2024

   show proficiency in testing methodologies.

On your resume, be sure to demonstrate your understanding of various testing methodologies, such as functional, integration, and performance testing. This shows employers that you're well-versed in the core responsibilities of a QA tester.

   Highlight automation and technical skills

Given the increasing role of automation in the QA field, it's essential to showcase any experience or knowledge you have with automated testing tools, scripting languages, or frameworks. Additionally, mention any relevant programming languages and technical skills that can demonstrate your ability to handle the technical aspects of QA testing.

Skills you can include on your Entry Level QA (Quality Assurance) Tester resume

Template 13 of 16: entry level qa (quality assurance) tester resume example.

An entry-level Quality Assurance tester can expect to be doing a lot of work that seems tedious or repetitive to most. They should have an excellent attention to detail and be thorough as they will spend most of their time identifying and documenting bugs. They should also be great at teamwork. The power of QA lies in the orchestration of a team to identify all the bugs in a software or application release, and it certainly is not a job that can be completed alone.

   Supplements limited work experience with related volunteer or school projects.

If you’re applying for an entry-level job, it’s a great idea to expand your work experience in this way. These can be school projects or volunteer projects you seek out, but make sure you clearly explain your successes with data. Try to highlight projects that use relevant skills in a QA role, whether that’s programming, software testing, bug fixing or website development.

   Highlights industry interest in extracurricular activities.

Another good way to show your involvement in the industry is to include your activity and leadership in clubs or sports. As above, you should point out what skills you think translate to your chosen career path and why. Soft skills like leadership, communication and teamwork are always transferable and are relevant to QA roles — so highlight them through your experiences.

Template 14 of 16: QA (Quality Assurance) Analyst/Specialist Resume Example

As a Quality Assurance (QA) Analyst or Specialist, you're a vital player in product development, helping make sure that all the bugs are identified and resolved before software gets to the customer. Lately, there's a shift towards automation in QA, so having experience with automated testing tools can be a real bonus. When crafting your resume, remember that hiring managers want to see a mix of hard skills (like knowledge of specific testing tools) and soft skills (like attention to detail). One more thing - in this field, employers love seeing concrete examples of your problem-solving prowess on your resume. In your QA resume, don't overlook the significance of showcasing your collaborative skills. More companies are adopting Agile methodologies, making it crucial for QA specialists to work effectively within cross-functional teams. Make sure your resume highlights experience with Agile or Scrum, if you have it. One last advice - continuously updating your skills can make the difference between a resume that gets set aside and one that earns an interview, as the QA field is ever-evolving.

Tips to help you write your QA (Quality Assurance) Analyst/Specialist resume in 2024

   include specific testing tools knowledge.

As a QA Analyst/Specialist, having a grasp of both manual and automated testing tools is essential. List the specific testing tools you've used, like JUnit or Selenium, as they are the ones that will grab a hiring manager's attention.

   Showcase project management skills

In the QA realm, you often need to manage multiple test plans simultaneously. Including past experiences where you successfully juggled multiple projects or led a testing team can showcase your ability to handle these scenarios in your future role.

Skills you can include on your QA (Quality Assurance) Analyst/Specialist resume

Template 15 of 16: qa (quality assurance) analyst/specialist resume example.

The roles of a Quality Assurance Specialist and a Quality Assurance Tester are quite similar. The biggest difference is that a QA Specialist is more likely to choose a more general or managerial path, and so those skill sets should be highlighted on your resume.

   Summary targets the intent of the resume, specializing in QA

Especially earlier in your career, it helps hiring managers to understand how you see your current position in relation to your desired career path. Consider it something of an elevator pitch. You have 30 seconds to influence how hiring managers are going to read the rest of your resume, so make it count.

   Demonstrate conversion from university-led program to workplace.

If you’re lucky enough to be singled out for placement programs early in your career, that’s a great thing for employers to know! It shows that you excelled enough to be taken note of, but also that you made the most of that time and entered the workplace with some solid (and accelerated) experience under your belt. Even better, highlight QA or software development experience to show recruiters that you’re technically minded.

Template 16 of 16: Medical Quality Assurance Inspector Resume Example

A medical quality assurance inspector is someone who ensures the products being manufactured at a facility meet specific standards. When it comes to medical equipment, this is particularly important. It’s the medical quality assurance inspectors' responsibility to inspect each piece of equipment post-production, using tools given by their employer, and meticulously record their findings after each inspection. If you want to go right into a job in medical quality assurance, an educational background in science or medicine will make your resume attractive to hiring managers. Hiring managers may also want to see certifications in quality assurance. When hiring for this role, managers will be looking for someone who demonstrates an eye for detail and superb communication skills.

Tips to help you write your Medical Quality Assurance Inspector resume in 2024

   start with a lower stakes quality assurance inspector role.

Most companies that produce a physical product have a quality assurance department. Medical devices are one of the most high-stakes products on the market, given that a faulty medical device can have serious consequences. Gaining a couple of years of experience in a “lower-stakes” industry allows you to learn the ropes in a less stressful environment, and shows hiring managers you have foundational experience inspecting products.

   Obtain quality assurance inspector certifications

Certifications show hiring managers you have the knowledge needed to competently inspect products and create reports. There are several certifications you can earn, such as the CQAP or CQI. You can also get a medical device quality assurance certification, which shows hiring managers you have specialized knowledge in inspecting medical devices.

Skills you can include on your Medical Quality Assurance Inspector resume

As a hiring manager who has recruited Quality Assurance professionals at companies like Microsoft, Apple, and Google, I have reviewed hundreds of resumes. I know what makes a strong resume that will get you noticed by top employers. Here are some tips to help your Quality Assurance resume stand out:

   Highlight your technical skills and tools

Employers want to see the specific technical skills and tools you have used in your Quality Assurance roles. Instead of simply listing the skills, provide examples of how you used them to deliver results.

• Performed manual and automated testing using Selenium, Cypress, and Postman to ensure high-quality software releases
• Developed and executed test plans and test cases using JIRA and TestRail, resulting in a 25% reduction in bug leakage
• Collaborated with development teams to identify and troubleshoot defects using debugging tools like Chrome DevTools and Xcode

   Quantify your impact with metrics

Use numbers and metrics to show the impact of your work. This helps employers understand the value you can bring to their organization.

• Tested software applications to ensure quality
• Identified and reported bugs and defects

Instead, quantify your accomplishments like this:

• Executed 500+ test cases per release, ensuring 99% test coverage and reducing post-release defects by 40%
• Identified and reported 150+ high-priority bugs, collaborating with developers to resolve them before release deadlines

   Show your experience with different testing types

Quality Assurance involves various types of testing, such as functional, performance, usability, and security testing. Showcase your experience with different testing types to demonstrate your versatility.

• Conducted functional testing on web and mobile applications, ensuring features worked as expected across different devices and browsers
• Performed load and stress testing using JMeter to identify performance bottlenecks and optimize application speed
• Collaborated with UX designers to conduct usability testing, gathering user feedback to improve application design and user experience

   Demonstrate your problem-solving skills

Quality Assurance professionals need strong problem-solving skills to identify and troubleshoot issues. Use examples to show how you have used your problem-solving skills to deliver results.

Investigated and identified root cause of a critical production issue impacting 50,000+ users. Collaborated with development and operations teams to implement a hotfix within 24 hours, minimizing downtime and user impact.

This example shows how you used your problem-solving skills to quickly identify and resolve a critical issue, demonstrating your value to the organization.

   Tailor your resume to the job description

Customize your resume for each job application to highlight the skills and experience most relevant to that specific role. This shows employers that you have taken the time to understand their needs and how you can contribute to their team.

For example, if the job description emphasizes experience with agile methodologies, make sure to highlight your experience working in agile teams and participating in agile ceremonies like daily stand-ups and retrospectives.

• Collaborated with cross-functional agile teams to plan and execute testing activities in 2-week sprints
• Participated in daily stand-ups, sprint planning, and retrospectives to continuously improve quality and delivery speed

   Include relevant certifications and training

Quality Assurance professionals often pursue certifications and training to stay up-to-date with the latest tools and best practices. Including relevant certifications and training on your resume can help you stand out from other candidates.

• Certified Software Quality Analyst (CSQA) - International Software Testing Qualifications Board (ISTQB)
• Agile Testing Certification - Scrum Alliance
• Completed training on Selenium WebDriver and JMeter

These certifications and training demonstrate your commitment to your profession and your ability to apply industry-standard practices to your work.

Writing Your Quality Assurance Resume: Section By Section

  header, 1. put your name first and make it stand out.

Your name should be the most prominent element in your resume header. Use a larger font size than the rest of your contact details to make it pop.

Compare these two examples:

• John Smith, 123 Oak St, New York, NY 10001 | (555) 123-4567 | [email protected]

Instead, format your header like this:

• John Smith New York, NY | (555) 123-4567 | [email protected]

By putting your name on its own line in a larger font, it becomes the focal point and makes it easier for hiring managers to remember you.

2. Include essential contact details only

In your resume header, stick to the key details hiring managers need to contact you:

• Phone number
• Professional email address
• LinkedIn profile URL
• City and state of residence

Avoid listing your full mailing address, as it's no longer expected and takes up valuable space. And never include personal details like your date of birth, marital status, or headshot. Keep your header concise and professional.

John Smith Seattle, WA | (555) 123-4567 | [email protected] | linkedin.com/in/johnsmith

3. Tailor your header to the QA role

If you're applying for a specific QA position, consider tailoring your resume header to better align with the role. For example:

• John Smith Senior QA Engineer San Francisco, CA | (555) 123-4567 | [email protected]

By adding your current or desired job title that matches the role you're applying for, you quickly convey to employers that you're a relevant candidate. However, avoid listing multiple job titles or stuffing your header with keywords, as it can appear cluttered and spammy.

Keep your header tailored but concise, so hiring managers can easily see your fit for the QA job at hand.

  Summary

A resume summary for a Quality Assurance (QA) role is optional, but it can be a valuable addition if you want to provide context or highlight key skills and experiences that may not be immediately evident from the rest of your resume. As a QA professional, your summary should focus on your ability to ensure product quality, identify and report issues, and collaborate with cross-functional teams. Avoid using an objective statement, as it is outdated and does not provide value to the employer.

To learn how to write an effective resume summary for your Quality Assurance resume, or figure out if you need one, please read Quality Assurance Resume Summary Examples , or Quality Assurance Resume Objective Examples .

1. Highlight your QA expertise

In your summary, showcase your QA expertise by mentioning your experience with specific testing methodologies, tools, and processes. This helps employers quickly understand your background and how you can contribute to their organization.

For example:

• Experienced Quality Assurance professional with 5+ years of expertise in manual and automated testing, ensuring high-quality software releases.
• Detail-oriented QA specialist skilled in developing and executing test plans, identifying and reporting defects, and collaborating with development teams to deliver exceptional products.

2. Quantify your achievements

Whenever possible, use metrics to quantify your achievements and demonstrate your impact in previous roles. This helps employers understand the scale and significance of your contributions.

Avoid vague statements like:

• Improved software quality and reduced bugs.

Instead, provide specific numbers:

• Implemented a comprehensive testing strategy that reduced production defects by 35% and increased customer satisfaction ratings by 20%.

3. Tailor your summary to the job

While it's essential to highlight your overall QA experience, make sure to tailor your summary to the specific job you're applying for. Review the job description and identify the key skills and requirements the employer is looking for, then incorporate those into your summary.

Quality Assurance professional with 7+ years of experience in the e-commerce industry. Skilled in developing and executing comprehensive test plans, collaborating with cross-functional teams, and ensuring the delivery of high-quality, user-friendly web and mobile applications. Proven track record of reducing defect leakage by 30% and improving time-to-market by 20% through the implementation of efficient testing processes and automation frameworks.

  Experience

The work experience section is the heart of your resume. It's where you show the impact you've made at each company. Hiring managers and recruiters look to this section to see how your career has progressed and to find evidence that you're the best candidate for the job.

In this section, we'll break down exactly what to include in your work experience section, and share tips to make your experience stand out to employers.

1. Focus on your impact and results

It's not enough to simply list your day-to-day responsibilities in your work experience section. Employers want to see the impact you made and the results you achieved.

For each role, think about how you contributed to the success of projects, initiatives, or the company as a whole. Then, use metrics and data to quantify your impact wherever possible.

• Implemented new testing procedures which reduced defect rate by 25% and improved customer satisfaction scores by 15%
• Developed and executed test plans for new software releases, resulting in a 98% pass rate and on-time delivery for all major milestones
• Led a team of 5 QA analysts to thoroughly test new features, catching and documenting 150+ bugs before release

2. Highlight your QA expertise and technical skills

Quality assurance roles require a mix of technical know-how, problem-solving skills, and attention to detail. Make sure your work experience section showcases your expertise in these areas.

Mention the specific QA methodologies, tools, and technologies you've used. This shows employers you have the technical chops to excel in the role.

• Tested software for bugs and issues
• Worked with developers to improve quality

Instead, get specific about your QA expertise:

• Expertise in Agile testing methodologies, including Scrum and Kanban
• Proficient with test automation tools such as Selenium, Appium, and JMeter
• Skilled in writing detailed bug reports and test cases using Jira and TestRail

3. Show your career progression

Employers like to see candidates who have grown and taken on more responsibility throughout their career. If you've been promoted or taken on leadership roles, make sure to highlight that in your work experience section.

One way to show progression is by listing your roles in reverse-chronological order, with your most recent position first. For each company, start with your most recent title and then list any previous roles below.

QA Manager, Acme Inc. (2019-Present) - Manage a team of 8 QA analysts and oversee all testing activities for web and mobile apps - Collaborate with cross-functional teams to define and implement QA strategy - Improved test coverage by 30% and reduced escaped defects by 20% QA Analyst, Acme Inc. (2016-2019) - Developed and executed manual and automated test cases for new features and releases - Reported and tracked bugs using Jira and collaborated with dev team on fixes - Contributed to a 15% reduction in customer-reported issues

  Education

The education section of your resume is where you showcase your academic background and training. When applying for quality assurance roles, it's important to highlight relevant coursework, certifications, and degrees that demonstrate your knowledge and skills in this field. Here are some tips to help you craft an effective education section on your resume.

1. List your degrees in reverse chronological order

Start with your most recent degree and work backwards. Include the name of the institution, the degree earned, and the year of graduation.

If you have a degree in a field related to quality assurance, such as computer science, engineering, or business, make sure to highlight it. You can also include relevant coursework, such as software testing, quality management, or statistics.

Bachelor of Science in Computer Science University of California, Los Angeles Graduated: 2020 Relevant Coursework: Software Testing and Quality Assurance Database Management Systems Data Structures and Algorithms

If you have multiple degrees, consider listing only the most relevant one for the quality assurance role you're applying for. This helps keep your resume concise and focused.

2. Include relevant certifications

Certifications demonstrate your expertise and commitment to the field of quality assurance. If you have earned any certifications, such as Certified Software Quality Analyst (CSQA) or Certified Quality Engineer (CQE), include them in your education section.

List the name of the certification, the issuing organization, and the date of completion. If the certification required passing an exam or completing a certain number of hours of training, you can mention that as well.

Certified Software Quality Analyst (CSQA) American Society for Quality (ASQ) Completed: 2022 Passed comprehensive exam covering software testing, quality assurance, and quality management principles Completed 40 hours of training and hands-on projects

Only include certifications that are relevant to quality assurance and recognized in the industry. Avoid listing generic or outdated certifications that may not add value to your resume.

3. Highlight your technical skills

Quality assurance professionals often need to have a strong technical background, especially when working with software or technology products. Use your education section to showcase your technical skills and knowledge.

If you have taken courses or earned certifications in specific programming languages, tools, or methodologies, list them. This can include things like Java, Python, Selenium, Agile, or Six Sigma.

Associate's Degree in Information Technology Community College of Denver Graduated: 2018 Technical Skills: Programming Languages: Java, Python, C++ Testing Tools: Selenium, JUnit, TestNG Methodologies: Agile, Scrum, Waterfall

Be specific about your technical skills and how you acquired them. This helps employers understand the depth of your knowledge and how it can be applied to the quality assurance role.

4. Keep it brief if you're a senior professional

If you have several years of experience in quality assurance, your education section can be brief. List your degree, institution, and graduation year, but avoid going into detail about coursework or projects.

Master of Science in Engineering Stanford University Bachelor of Science in Computer Science University of Michigan

However, if your education is not directly related to quality assurance or is outdated, consider leaving it off your resume entirely. Your work experience and accomplishments will carry more weight.

• Associate's Degree in Liberal Arts Community College of Philadelphia Graduated: 1985

As a senior quality assurance professional, your education becomes less important than your work experience and accomplishments. Focus on highlighting your most impressive and relevant degrees or certifications.

Action Verbs For Quality Assurance Resumes

A big part of your career as a Quality Assurance professional is going to be in generating reports that identify vulnerabilities in software. Those reports should be data-driven, persuasive, and clear so that the myriad of stakeholders involved in the design of the application or software can act on it. In some ways, it’s very similar to how you write a resume. You choose a word that suggests the course of action in a descriptive way, include the supporting data, and don’t use seven words when you can use five. Clarity and impact are key!

• Systematized
• Demonstrated
• Facilitated
• Implemented

For a full list of effective resume action verbs, visit Resume Action Verbs .

Action Verbs for Quality Assurance Resumes

Skills for quality assurance resumes.

As a Quality Assurance professional in the tech industry, the skill box is your best friend. You can quickly and easily tell employers which skills you can bring to bear and you can even point towards your forward thinking in a growing field (such as including machine learning tools). It’s also a simple and easy way to target your resume to the job listing. This puts you in a better position with ATS (applicant tracking system) filters. Remember that a skill in and of itself doesn’t create a robust picture of your abilities. As a Quality Assurance professional, you’re going to be expected to use data to make your argument. What better way to show you’re expert at this than having data driven bullet points on your resume?

• Quality Assurance
• Manual Testing
• Regression Testing
• Test Planning
• Test Automation
• Software Quality Assurance
• Software Testing
• Agile Methodologies
• Functional Testing

Quality Control

• Engineering
• Manufacturing
• Statistical Process Control (SPC)
• Failure Mode and Effects Analysis (FMEA)
• QA Engineering
• Good Manufacturing Practice (GMP)
• Quality Management

How To Write Your Skills Section On a Quality Assurance Resumes

You can include the above skills in a dedicated Skills section on your resume, or weave them in your experience. Here's how you might create your dedicated skills section:

Skills Word Cloud For Quality Assurance Resumes

This word cloud highlights the important keywords that appear on Quality Assurance job descriptions and resumes. The bigger the word, the more frequently it appears on job postings, and the more 'important' it is.

How to use these skills?

Other engineering resumes.

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• Pharmaceutical Resume Example

Resume Examples

• Common Tasks & Responsibilities
• Top Hard & Soft Skills
• Action Verbs & Keywords
• Resume FAQs
• Similar Resumes

Common Responsibilities Listed on Pharmaceutical Resumes:

• Research and Development: Conduct research to develop new drugs and improve existing ones. This involves laboratory experiments, clinical trials, and data analysis to ensure the safety and efficacy of the drugs.
• Quality Control: Ensure the quality of drugs produced by the company. This involves testing samples of drugs for purity, potency, stability, and safety. Any deviations from the set standards must be identified and corrected.
• Regulatory Compliance: Ensure that all activities of the pharmaceutical company comply with local and international laws and regulations. This includes keeping up-to-date with changes in regulations and implementing necessary changes in the company's operations.
• Production Planning: Plan and oversee the production of drugs. This involves coordinating with other departments to ensure that the necessary raw materials are available, the production process is efficient, and the finished products meet quality standards.
• Product Launch: Plan and execute the launch of new drugs. This involves coordinating with marketing, sales, and other departments to ensure a successful launch.
• Post-Market Surveillance: Monitor the safety and effectiveness of drugs after they have been launched. This involves collecting and analyzing data from patients, healthcare providers, and other sources.
• Pharmacovigilance: Monitor and report any adverse effects of drugs. This involves collecting data from various sources, analyzing it, and reporting it to regulatory authorities.
• Training and Development: Train and develop staff in the pharmaceutical company. This involves identifying training needs, developing training programs, and evaluating their effectiveness.

Speed up your resume creation process with the AI-Powered Resume Builder . Generate tailored achievements in seconds for every role you apply to.

Pharmaceutical Resume Example:

• Led a team of researchers and scientists in the successful development and launch of a new drug, resulting in FDA approval and a 30% increase in market share within the first year.
• Implemented a quality control system that reduced product defects by 20% and improved overall product quality, leading to increased customer satisfaction and repeat business.
• Developed and implemented a training program for new employees, resulting in a 50% reduction in onboarding time and improved productivity.
• Oversaw the production planning process, optimizing resource allocation and reducing production costs by 15% while maintaining high product quality standards.
• Led the successful launch of a new drug, coordinating with marketing and sales teams to achieve a 25% increase in sales within the first quarter.
• Implemented a post-market surveillance system, resulting in early detection and mitigation of potential safety issues, ensuring compliance with regulatory requirements.
• Conducted extensive research and development activities, resulting in the discovery of a new drug candidate with potential for significant therapeutic impact.
• Implemented a pharmacovigilance program, leading to the identification and reporting of adverse drug reactions, ensuring patient safety and compliance with regulatory guidelines.
• Developed and delivered training programs for staff, resulting in improved knowledge and skills, and increased efficiency in day-to-day operations.
• Drug development and launch
• Team leadership and management
• Quality control implementation
• Employee training and development
• Production planning and optimization
• Resource allocation
• Cost reduction strategies
• Cross-functional collaboration with marketing and sales teams
• Post-market surveillance and safety compliance
• Extensive research and development
• Pharmacovigilance program implementation
• Adverse drug reaction identification and reporting
• Regulatory compliance and guidelines
• Staff training and development
• Efficiency improvement strategies
• Knowledge of FDA approval process
• Risk management and mitigation
• Strategic planning and execution
• Project management
• Data analysis and interpretation
• Excellent communication skills
• Problem-solving abilities
• Attention to detail
• Time management skills
• Understanding of pharmaceutical market trends.

Top Skills & Keywords for Pharmaceutical Resumes:

Hard skills.

• Drug Development Process
• Good Manufacturing Practices (GMP)
• Regulatory Compliance
• Quality Assurance and Control
• Clinical Trials Management
• Pharmacovigilance and Drug Safety
• Pharmaceutical Formulation
• Pharmaceutical Analysis
• Pharmaceutical Packaging
• Pharmaceutical Manufacturing
• Pharmaceutical Sales and Marketing
• Pharmaceutical Research and Development

Soft Skills

• Attention to Detail
• Analytical Thinking
• Problem Solving
• Communication Skills
• Time Management
• Adaptability
• Customer Service
• Organization
• Critical Thinking
• Interpersonal Skills

Resume Action Verbs for Pharmaceuticals:

• Implemented
• Collaborated
• Coordinated
• Investigated
• Streamlined

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Resume FAQs for Pharmaceuticals:

How long should i make my pharmaceutical resume, what is the best way to format a pharmaceutical resume, which keywords are important to highlight in a pharmaceutical resume, how should i write my resume if i have no experience as a pharmaceutical, compare your pharmaceutical resume to a job description:.

• Identify opportunities to further tailor your resume to the Pharmaceutical job
• Improve your keyword usage to align your experience and skills with the position
• Uncover and address potential gaps in your resume that may be important to the hiring manager

Complete the steps below to generate your free resume analysis.

Related Resumes for Pharmaceuticals:

Pharmaceutical manager, pharmaceutical rep, pharmacy tech, medical technologist, certified medical assistant, medical assistant, medical administrative assistant, medical support assistant.

Quality Assurance Specialist resume examples for 2024

A quality assurance specialist resume should highlight experience that aligns with the organization's mission and strategic plan. This includes showcasing skills such as GMP, FDA, continuous improvement, and quality standards. Cari Ann Kreienhop , MPA Program Manager and Advisor at the University of Kansas, points out that it's important to "match their resume experience to the job posting" and to highlight achievements within the context of the organization's goals. This helps hiring managers quickly see how the applicant can contribute to the organization's growth.

Quality Assurance Specialist resume example

How to format your quality assurance specialist resume:.

• Use the job title 'Quality Assurance Specialist' in your resume to match your application. Avoid using a generic job title or overly specific internal titles
• Highlight quantifiable achievements in your work experience, such as 'Maximized profitability by establishing compliant procedures' or 'Consolidated six sites into one SharePoint site'. Avoid listing responsibilities without accompanying results
• Aim to fit your resume on one page, focusing on recent and relevant experience for Quality Assurance Specialist roles. Recruiters appreciate concise and impactful resumes

Choose from 10+ customizable quality assurance specialist resume templates

Choose from a variety of easy-to-use quality assurance specialist resume templates and get expert advice from Zippia’s AI resume writer along the way. Using pre-approved templates, you can rest assured that the structure and format of your quality assurance specialist resume is top notch. Choose a template with the colors, fonts & text sizes that are appropriate for your industry.

Quality Assurance Specialist resume format and sections

1. add contact information to your quality assurance specialist resume.

Quality Assurance Specialist Resume Contact Information Example # 1

Montgomery, AL 36043| 333-111-2222 | [email protected]

2. Add relevant education to your quality assurance specialist resume

Your resume's education section should include:

• The name of your school
• The date you graduated ( Month, Year or Year are both appropriate)
• The name of your degree

If you graduated more than 15 years ago, you should consider dropping your graduation date to avoid age discrimination.

Optional subsections for your education section include:

• Academic awards (Dean's List, Latin honors, etc. )
• GPA (if you're a recent graduate and your GPA was 3.5+)
• Extra certifications
• Academic projects (thesis, dissertation, etc. )

Other tips to consider when writing your education section include:

• If you're a recent graduate, you might opt to place your education section above your experience section
• The more work experience you get, the shorter your education section should be
• List your education in reverse chronological order, with your most recent and high-ranking degrees first
• If you haven't graduated yet, you can include "Expected graduation date" to the entry for that school

Check More About Quality Assurance Specialist Education

Quality Assurance Specialist Resume Relevant Education Example # 1

Bachelor's Degree In Business 1999 - 2002

American InterContinental University Chandler, AZ

Quality Assurance Specialist Resume Relevant Education Example # 2

Bachelor's Degree In Business 2005 - 2008

Ohio State University Columbus, OH

3. Next, create a quality assurance specialist skills section on your resume

Your resume's skills section should include the most important keywords from the job description, as long as you actually have those skills. If you haven't started your job search yet, you can look over resumes to get an idea of what skills are the most important.

Here are some tips to keep in mind when writing your resume's skills section:

• Include 6-12 skills, in bullet point form
• List mostly hard skills ; soft skills are hard to test
• Emphasize the skills that are most important for the job

Hard skills are generally more important to hiring managers because they relate to on-the-job knowledge and specific experience with a certain technology or process.

Soft skills are also valuable, as they're highly transferable and make you a great person to work alongside, but they're impossible to prove on a resume.

Example of skills to include on an quality assurance specialist resume

GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

CFR, or Code of Federal Regulations, is the codification of general and permanent regulations published in the federal register by executive agencies and departments of the government of the federation. Its aim is to present the official and complete text of government regulations in one organized publication and provide a comprehensive reference for anyone who needs to know.

Continuous improvement is an ongoing process of improvement of products, services, and processes with the help of innovative ideas. It is an organized approach that helps an organization to find its weaknesses and improve them.

Quality standards are a specific level of standards of products that are set by the companies for the customers that have to be met and maintained throughout the process until the time of delivery. Quality standards are information that includes the customer's requirements, guidelines, and characteristics for the needed final product or service.

A management system is a set of policies, processes, and procedures taken by an organization or a business to ensure it can fulfill its tasks and achieve its objectives. A management system makes sure that the company excels financially and improves the user experience. The management system also takes care of the worker's and employees' needs and manages their workload and oversees their performance. Apart from interior matters of the company, a management system also deals with exterior matters like legislations, tax matters, and law issues.

Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.

Top Skills for a Quality Assurance Specialist

• Patients , 5.4%
• CAPA , 4.3%
• Other Skills , 79.4%

4. List your quality assurance specialist experience

The most important part of any resume for a quality assurance specialist is the experience section. Recruiters and hiring managers expect to see your experience listed in reverse chronological order, meaning that you should begin with your most recent experience and then work backwards.

Don't just list your job duties below each job entry. Instead, make sure most of your bullet points discuss impressive achievements from your past positions. Whenever you can, use numbers to contextualize your accomplishments for the hiring manager reading your resume.

It's okay if you can't include exact percentages or dollar figures. There's a big difference even between saying "Managed a team of quality assurance specialists" and "Managed a team of 6 quality assurance specialists over a 9-month project. "

Most importantly, make sure that the experience you include is relevant to the job you're applying for. Use the job description to ensure that each bullet point on your resume is appropriate and helpful.

• Applied payments to customers' accounts, issued money orders, and posted payments through money gram.
• Ensured customer satisfaction with all complaints through up-to-date knowledge of store policies.
• Worked with my mentor to learn and watch CMS, and RTA by showing me the reporting styles used.
• Adhered to proper procedures and used written procedural language
• Cashed Checks (Payroll, government etc.)
• Performed growth promotion testing on all media used in Microbiology laboratory.
• Implemented procedures and industry best work practices to enhance regulatory compliance and capabilities of the microbiology laboratory
• Developed metrics for demonstrating the performance of the Microbiology Laboratory and Cleanroom.
• Conducted variety of microbiological testing on medical devices in a FDA regulated clean room following GMP.
• Performed assigned scientific research and analytical functions within a microbiology/virology/parasitology laboratory in a major medical/surgical acute care center.
• Monitored and participated in improving processes for quality improvements in tech troubleshooting procedures.
• Helped develop and implement new safety and installation policies and procedures.
• Communicated with customers and supervisors.
• Developed methods, procedures and reporting of Quality Assurance and operational functions.
• Generated tracking and trend reports using Excel, Outlook and PowerPoint software programs.
• Performed an Internal Audit assignment for a PwC fortune 500 corporation.
• Communicated daily in Arabic with other PWC offices in other Arab countries.
• Performed various testing procedures in order to ensure compliance with corporate policies and instructions.
• Developed requirements documents, processes and procedures, flow/RACI charts, leadership presentations, and various other business analysis documents.
• Worked with team members across multiple PwC offices and lines of services to achieve deliverable deadlines.

5. Highlight quality assurance specialist certifications on your resume

Specific quality assurance specialist certifications can be a powerful tool to show employers you've developed the appropriate skills.

If you have any of these certifications, make sure to put them on your quality assurance specialist resume:

• Certified Quality Auditor (CQA)
• Certified Pharmacy Technician (CPhT)
• Certified Nurse Assistant (CNA)
• Certified Billing and Coding Specialist (CBCS)
• Six Sigma Green Belt
• Certified Quality Assurance Professional (CQAP)
• Certified Quality Engineer (CQE)
• Certified Quality Technician (CQT)
• Certified Quality Improvement Associate (CQIA)
• Master Certified Electronics Technician (CETma)

6. Finally, add an quality assurance specialist resume summary or objective statement

A resume summary statement consists of 1-3 sentences at the top of your quality assurance specialist resume that quickly summarizes who you are and what you have to offer. The summary statement should include your job title, years of experience (if it's 3+), and an impressive accomplishment, if you have space for it.

Remember to emphasize skills and experiences that feature in the job description.

Common quality assurance specialist resume skills

• Corrective Action
• Continuous Improvement
• Quality Standards
• Management System
• Quality System
• Excellent Organizational
• Process Improvement
• Internal Audit
• Product Quality
• Quality Issues
• Test Results
• Quality Assurance Program
• Quality Audits
• Excellent Interpersonal
• Data Analysis
• Test Scripts
• Preventive Actions
• Customer Complaints
• Qa Management
• Regulatory Compliance
• Audit Findings
• External Audits
• Training Materials
• Federal Regulations
• Training Programs
• Environmental Monitoring
• Technical Assistance
• Product Releases

Quality Assurance Specialist Jobs

Links to help optimize your quality assurance specialist resume.

• How To Write A Resume
• List Of Skills For Your Resume
• How To Write A Resume Summary Statement
• Action Words For Your Resume
• How To List References On Your Resume

Quality Assurance Specialist resume FAQs

What are the duties of a quality assurance specialist, search for quality assurance specialist jobs.

Updated April 25, 2024

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

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• • Directed a team to conduct over 30 GxP compliance audits annually, ensuring adherence to international regulations and company SOPs.
• • Implemented a Quality Management System, reducing non-compliance incidents by 25% in the first year.
• • Spearheaded a cross-functional initiative to standardize pharmacovigilance processes, enhancing safety reporting efficiency by 15%.
• • Oversaw the development and delivery of a targeted auditor training program, boosting department audit capacity by 20%.
• • Managed the successful transition to a new electronic audit documentation system, improving data retrieval time by 30%.
• • Cultivated relationships with regulatory bodies, resulting in a 10% decrease in findings during external inspections.
• • Conducted over 50 site audits, ensuring compliance with study protocols and regulatory requirements.
• • Enhanced site monitoring procedures, leading to a 40% reduction in critical findings.
• • Collaborated with data management teams to streamline data captures, which reduced reporting errors by 5%.
• • Developed and led a region-wide initiative for continual education on GxP, engaging over 100 clinical staff.
• • Authored comprehensive audit reports that contributed to the improvement of trial quality and compliance.
• • Analyzed clinical trial data for 20+ studies, ensuring over 98% data accuracy and integrity.
• • Contributed to the development of a user-friendly database tool, increasing productivity by 15%.
• • Played a key role in a task force that reduced data query response times by 35%.
• • Provided crucial analytical support resulting in the on-time launch of 3 major clinical study reports.

5 Quality Assurance Auditor Resume Examples & Guide for 2024

Your quality assurance auditor resume must highlight your attention to detail. Demonstrate your ability to identify and document inconsistencies and errors. Showcase on your resume your proficiency with quality audit tools and methodologies. Your expertise should reflect a strong understanding of regulatory standards and compliance requirements.

All resume examples in this guide

Traditional

Resume Guide

Resume Format Tips

Resume Experience

Skills on Resume

Education & Certifications

Resume Summary Tips

Additional Resume Sections

Key Takeaways

As a quality assurance auditor, articulating your meticulous attention to detail and capacity to identify systemic issues can be a daunting challenge on a resume. Our guide offers expert advice on translating your complex auditing skills into concise, impactful bullet points that will catch an employer’s eye.

• The most straightforward and effective resume format, ensuring your quality assurance auditor resume stands out among numerous candidate profiles;
• The significance of the top one-third of your resume, including the header, summary or objective, and skills section, and its impact on recruiters;
• Frameworks and structures used by real quality assurance auditor professionals, offering insights on how to enhance your resume with industry-specific expertise;
• A variety of quality assurance auditor resume sections that bolster your profile, showcasing your comprehensive capabilities and distinctiveness.

Gaining insights from the best has never been easier. Explore more quality assurance auditor resume examples below:

• Test Manager Resume Example
• Quality Assurance Supervisor Resume Example
• Quality Specialist Resume Example
• Quality Auditor Resume Example
• Data Quality Analyst Resume Example
• Quality Control Manager Resume Example
• Quality Control Technician Resume Example
• Quality Supervisor Resume Example
• Quality Manager Resume Example
• Quality Assurance Officer Resume Example

Don't stress out over your quality assurance auditor resume format

Remember, the elaborate design of your quality assurance auditor resume isn't what impresses recruiters most. They are primarily searching for candidates who meet the job requirements. The main aim of your resume should be to clearly and concisely explain why employers should hire you.

Here are four straightforward steps to consider in your quality assurance auditor resume design:

• Organize your resume based on experience : Start with your most recent roles. Besides using reverse chronological order, choose jobs relevant to the position you're applying for.
• Include your contact details (and portfolio or LinkedIn link) in your resume's header to ensure recruiters can easily reach you. If considering adding a professional photo, check acceptable practices in different countries first.
• Don't omit essential quality assurance auditor resume sections such as the summary or objective, experience, and education. These sections should reflect your career progression and align with job requirements.
• Maintain conciseness in your resume. For those with less than ten years of experience, a one-page format is advisable.

Regarding the format to submit your quality assurance auditor resume, PDF is preferable . PDFs are more likely to maintain their formatting when processed through recruitment software or ATS, saving you time in the application process.

When selecting a font for your quality assurance auditor resume, consider the following:

• Choose ATS-friendly fonts such as Exo 2, Volkhov, Lato, etc., to keep your resume's content legible;
• All serif and sans-serif fonts are easily readable by ATS;
• While Arial and Times New Roman are common choices, opting for unique typography can help your resume stand out.

Concerned about ATS compatibility with charts and infographics? Our recent study has debunked this and other myths .

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If you happen to have some basic certificates, don't invest too much of your quality assurance auditor resume real estate in them. Instead, list them within the skills section or as part of your relevant experience. This way you'd ensure you meet all job requirements while dedicating your certificates to only the most in-demand certification across the industry.

The five (plus) definite sections your resume for a quality assurance auditor job should include are:

• Header with your headline, contact details, and/or a preview of your work
• Summary (or objective) to pinpoint how your success aligns with the role
• Experience with bullets of your most relevant achievements in the field
• Skills to integrate vital job requirements (both technical and personal)
• Your further dedication to the field, showcased via relevant higher education and/or certifications

What recruiters want to see on your resume:

• Proven experience in conducting quality audits and understanding of relevant standards (e.g., ISO 9001, ISO 13485, AS9100).
• Detail-oriented with strong analytical skills to identify non-conformances and potential areas of improvement.
• Certifications relevant to quality assurance, such as Certified Quality Auditor (CQA) or Lead Auditor certification.
• Experience with quality management systems (QMS) and proficiency in using audit-related software tools.
• Excellent communication and interpersonal skills to effectively report audit findings and collaborate with cross-functional teams.

Guide to your most impressive quality assurance auditor resume experience section

When it comes to your resume experience , stick to these simple, yet effective five steps:

• Show how your experience is relevant by including your responsibility, skill used, and outcome/-s;
• Use individual bullets to answer how your experience aligns with the job requirements;
• Think of a way to demonstrate the tangible results of your success with stats, numbers, and/or percentages ;
• Always tailor the experience section to the quality assurance auditor role you're applying for - this may sometimes include taking out irrelevant experience items;
• Highlight your best (and most relevant) achievements towards the top of each experience bullet.

You're not alone if you're struggling with curating your experience section. That's why we've prepared some professional, real-life quality assurance auditor resume samples to show how to best write your experience section (and more).

• Developed and implemented a rigorous quality assurance program at PharmaCorp Inc., slashing defect rates by 35% over a 2-year period through meticulous process audits.
• Led a cross-departmental initiative to standardize SOPs, which increased operational efficiency and reduced training time for new auditors by 25%.
• Championed the adoption of statistical process control techniques, enhancing the company’s ability to predict and preempt quality issues.
• Oversaw the development and execution of a custom Quality Management System for TechGiant Solutions, enhancing compliance with international standards ISO 9001 and ISO 27001.
• Achieved a consistent audit pass rate of over 98% for all external audits, establishing TechGiant Solutions as a leader in software quality assurance practices.
• Cultivated a team of 15 quality assurance auditors, empowering them with tools and methodologies to drive continuous improvement initiatives.
• Conducted over 150 process audits per year at FoodSafety Inc., ensuring compliance with FDA and other regulatory standards, directly contributing to the company’s strong food safety record.
• Provided detailed actionable feedback from audits, which contributed to a 20% improvement in quality control metrics across several product lines.
• Fostered strong relationships with production and supply chain teams, resulting in a cohesive approach to quality improvements and compliance.
• Successfully navigated GlobalTech Enterprises through four major industry compliance audits with zero non-conformances - a first for the organization.
• Implemented enhanced data analysis techniques for quality trending, leading to a 40% reduction in customer complaints for software products.
• Collaborated with R&D to integrate quality standards into the early design phases, thereby reducing rework costs by approximately 15% annually.
• Executed comprehensive quality audits across 10 manufacturing sites for AutoWorks International, driving standardization and alignment with industry best practices.
• Identified key areas for process optimization, leading to a reduction in cycle time by an average of 18% across the audited sites.
• Initiated a corrective action tracking system that reduced the closure time for audit findings by 50%, significantly improving operational responsiveness.
• Orchestrated the transition to a fully automated audit reporting system at MedEquip Services, cutting report generation time by 60% while maintaining detail and accuracy.
• Served as the primary quality liaison for supplier audits, tightening the feedback loop and elevating supplier quality rating by 22%.
• Directed the internal audit process, leading to MedEquip Services’ successful recertification in ISO 13485 for medical devices, underscoring the company’s commitment to quality.
• Streamlined the quality audit process for CleanEnergy Systems through the introduction of lean auditing principles, resulting in a 30% increase in audit efficiency.
• Uncovered a critical compliance gap in the supply chain process that, once addressed, resulted in a prestigious industry award for supply chain excellence.
• Conducted regular training workshops for new auditors, increasing departmental knowledge and fostering a culture of continuous learning and improvement.
• Developed an innovative risk-based auditing strategy at FinTech Innovations, leading to more targeted and effective quality reviews and a 20% improvement in overall risk management.
• Pioneered a quarterly audit insights report, which became a critical tool for senior management in strategic decision-making to enhance product quality.
• Partnered with IT to create an integrated audit platform, improving the traceability and visibility of audit findings, corrective actions, and preventive measures.

Quantifying impact on your resume

• Include the number of quality audits performed to demonstrate your experience and volume of work handled.
• State the percentage of process improvements implemented post-audit to show your tangible impact on operations.
• List the amount of cost savings achieved through identified quality enhancements to highlight your contribution to profitability.
• Mention the number of corrective action plans developed to exemplify problem-solving skills.
• Detail the reduction in defect rates achieved to showcase your ability to enhance product quality.
• Quantify the number of training sessions conducted to portray your role in improving team competencies.
• Cite specific examples of risk mitigation to demonstrate how your efforts have reduced potential losses.
• Describe the expansion of quality standards across how many product lines to show your influence on company-wide practices.

Action verbs for your quality assurance auditor resume

Lacking relevant quality assurance auditor resume experience?

Learn how to write your quality assurance auditor resume experience in spite of having no real-world (or applicable) experience for the job.

You should:

• Feature relevant projects or publications that could impress recruiters or showcase that you have the basic skill set for the job
• Shift the focus towards your people (communication, organization, etc.) skills to demonstrate that you're a quick learner and can easily adapt to a new environment
• Use the resume objective to not only highlight your accomplishments but also map out how your career plans are perfectly aligned with the company's vision
• Select either the functional-skill-based resume format (that puts the focus on your skills) or the hybrid one (balancing expertise with skills).

Recommended reads:

• Should You Include Eagle Scout On Your Resume?
• How To List Certifications On A Resume (Examples Included)

The more time and effort you've put into obtaining the relevant certificate, the closer to the top it should be listed. This is especially important for more senior roles and if the company you're applying for is more forward-facing.

The heart and soul of your quality assurance auditor resume: hard skills and soft skills

If you read between the lines of the quality assurance auditor role you're applying for, you'll discover that all requirements are linked with candidates' hard skills and soft skills.

What do those skills have to do with your application?

Hard or technical skills are the ones that hint at your aptitude with particular technologies. They are easy to quantify via your professional experience or various certifications.

Meanwhile, your soft skills are more difficult to assess as they are personality traits, you've gained thanks to working in different environments/teams/organizations.

Your quality assurance auditor resume skills section is the perfect opportunity to shine a light on both types of skills by:

• Dedicating a technical skills section to list up to six technologies you're apt at.
• Focusing a strengths section on your achievements, thanks to using particular people skills or technologies.
• Including a healthy balance of hard and soft skills in the skills section to answer key job requirements.
• Creating a language skills section with your proficiency level - to hint at an abundance of soft skills you've obtained, thanks to your dedication to learning a particular language.

Within the next section of this guide, stay tuned for some of the most trending hard skills and soft skills across the industry.

Top skills for your quality assurance auditor resume:

Quality Control Procedures

Regulatory Compliance

Auditing Standards

Risk Assessment

Data Analysis

Documentation Management

ISO Standards Knowledge

Corrective and Preventive Actions (CAPA)

Quality Management Systems (QMS)

Statistical Analysis

Attention to Detail

Critical Thinking

Analytical Skills

Problem-solving

Communication

Time Management

Objectivity

Adaptability

List all your relevant higher education degrees within your resume in reverse chronological order (starting with the latest). There are cases when your PhD in a particular field could help you stand apart from other candidates.

The basics of your quality assurance auditor resume certifications and education sections

Improve the education and certification sections of your quality assurance auditor resume by:

• Dedicating more prominent space to certificates that are more recent and have helped you update your skill set
• Keeping all the information you list to the basics: certificate/degree name, institution, and graduation dates
• Writing supplementary information in the details of your certification or education section, only if you lack experience or want to show further skill alignment
• Including your credential or license number, only if the information is valid to your application or certification

Within quality assurance auditor job adverts, relevant education, and certification are always listed within the key prerequisite for the role.

Ensure you meet all job requirements with some of the leading certificates in the industry:

The top 5 certifications for your quality assurance auditor resume:

• Certified Quality Auditor (CQA) - American Society for Quality (ASQ)
• ISO 9001:2015 Lead Auditor (ISO LA) - International Organization for Standardization
• Certified Quality Improvement Associate (CQIA) - American Society for Quality (ASQ)
• Exemplar Global Certified Auditor - Exemplar Global
• International Register of Certificated Auditors (IRCA) Lead Auditor - International Register of Certificated Auditors

Highlight any significant extracurricular activities that demonstrate valuable skills or leadership.

• Perfecting the Education Section on Your Resume
• How to List GPA on Your Resume

Practical guide to your quality assurance auditor resume summary or objective

First off, should you include a summary or objective on your quality assurance auditor resume?

We definitely recommend you choose the:

• Resume summary to match job requirements with most noteworthy accomplishments.
• Resume objective as a snapshot of career dreams

Both the resume summary and objective should set expectations for recruiters as to what your career highlights are.

These introductory paragraphs (that are no more than five sentences long) should help you answer why you're the best candidate for the job.

Industry-wide best practices pinpoint that the quality assurance auditor resume summaries and objectives follow the structures of these samples:

Resume summaries for a quality assurance auditor job

• With over 10 years of experience enforcing rigorous quality standards in the pharmaceutical industry, this seasoned auditor has developed a fine-tuned expertise in GMP, FDA regulations, and ISO 9001. Recognized for a career-defining project that reduced product defects by 30%, this candidate offers a robust understanding of risk management and process improvement methodologies.
• Transitioning from a fast-paced career in aerospace engineering, this professional brings 8 years of experience in systems analysis and a proven track record of implementing Six Sigma methodologies to enhance product quality. Eager to leverage a strong analytic background to shift into quality assurance, with the goal of driving excellence in product integrity and customer satisfaction.
• Embarking on a career in quality assurance, this recent biochemistry graduate is driven by a passion for operational excellence and a rigorous academic background in laboratory research and statistical analysis. Seeking to apply a fresh perspective and an unwavering commitment to ensuring the highest quality standards are achieved in every product cycle.
• After a successful 6-year tenure in management consulting with a focus on process optimization for Fortune 500 companies, this professional is poised to apply transferable skills to the domain of quality assurance. Carries an exceptional ability to identify inefficiencies, implement strategic quality control plans, and has a solid foundation in LEAN management principles.
• Having honed analytical and critical thinking skills over 5 years of experience in software testing, this QA auditor is eager to contribute a meticulous approach to defect detection and compliance with industry standards. Acknowledged for leading a cross-functional team to win the ‘Best Quality Initiative’ award in a previous role, the candidate excels in driving continuous improvement efforts.
• Equipped with a Bachelor's degree in Industrial Engineering and ignited by an enthusiasm to promote Quality First mindsets, this aspirant is primed to dive into a quality assurance auditor role. Aiming to utilize an exemplary academic record in process engineering and an internship experience at a leading manufacturing firm to uphold superior quality benchmarks and ensure product reliability.

More sections to ensure your quality assurance auditor resume stands out

If you're looking for additional ways to ensure your quality assurance auditor application gets noticed, then invest in supplementing your resume with extra sections, like:

• Publications;

These supplementary resume sections show your technical aptitude (with particular technologies and software) and your people skills (gained even outside of work).

Key takeaways

• Ensure your quality assurance auditor resume uses a simple, easy-to-read format that reflects upon your experience and aligns with the role;
• Be specific within the top one-third of your resume (header and summary or objective) to pinpoint what makes you the ideal candidate for the quality assurance auditor role;
• Curate information that is tailored to the job by detailing skills, achievements, and actual outcomes of your efforts;
• List your certifications and technical capabilities to demonstrate your aptitude with specific software and technologies;
• The sections you decide on including on your quality assurance auditor should pinpoint your professional expertise and personality.

Looking to build your own Quality Assurance Auditor resume?

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Quality Assurance Chemist Resume Samples

A Quality Assurance Chemist is a specialized chemist who undertakes the duty of measuring and testing lab materials as per the industry-specific standard procedures. While the duties vary based on the manufacturing or pharmaceutical field , a successful Quality Assurance Chemist Resume mentions the following core duties and responsibilities – preparing and testing samples from all phases of the manufacturing process ; meeting the standards or requirements of the project; employing a variety of methods to perform the testing; preparing documents, and taking responsibility for minor troubleshooting and repair; preserving workplace safety and working carefully with hazardous materials.

These professionals should denote the following skills on their resumes – chemistry expertise, computer competencies, effective communication skills, lab skills, skillful in performing a variety of analysis on drug substances; and excellent scientific writing skills. Employers select candidates having a degree n Chemistry or a related field.

• Resume Samples
• Quality Assurance Chemist

Quality Assurance Chemist Resume

Headline : An energetic, motivated and highly dynamic person with strong working skills and a broad range of hands-on and theoretical experience ranging from chemical research, analysis, and testing within the food and pharmaceutical industry. Adept at providing support and developing new processes through ongoing work, defect resolution and enhancement solutions.

Skills : Quality Assurance, Project Management, Research, Microsoft Office, Supervisor, Teamwork, Leadership Development.

Description :

• Promoted to head CIP (clean in place) validator Established guidelines for productivity extensions from 72hr runtime to 144 hour runtime from Aerobic Plate Count testing to prove sterility of equipment Used beverage application skills and creativity to develop prototypes for line extensions and cost reductions.
• Recruited for the tablets facility to provide high level analytical support for manufacturing changes, process validation and scale-ups.
• Performed testing on particle size, bulk density, content uniformity, raw materials, dissolution, assay and impurity testing.
• Validated methods as per standard procedures.
• Validated processes for new drug products or new product strengths.
• Conducted timely and effective laboratory investigations, OOS/OOT investigations and CAPAs (Corrective Action and Preventative Action plans), identify deviations and non-conformances in projects, in accordance with current GMP, FDA, and CFR regulatory requirement.
• Communicated with laboratory personnel, supervisors and management on potential gaps or issues when identified.

Objective : To obtain a technical Quality Assurance Chemist position utilizing my chemical experience and laboratory skills Consistently disciplined in time management, priority assessment, and goal setting. Highly skilled in bringing products to market. Sound understanding of the creative process. Excellent problem-solving skills. Exceptionally strong communication and interpersonal skills.

Skills : Microsoft Office, IQS System, Vantage System, Pharmacology, Minitab.

• Developed and implemented new analytical test methods.
• Calibrated instruments to ensure they are providing accurate data.
• Provided routine maintenance, repair and troubleshoot problems with analytical instruments.
• Experienced using GC-FID, GC-TCD, RI-HPLC, DAD-HPLC, ICP.
• Requisitioned all parts, gases, chemicals and standards required using SAP entry system.
• Performed all non-routine analyses.
• Provided customer feedback.

Summary : Quality Assurance Chemist Professional with extensive pharmaceutical industry experience. 10+ years experience designing and executing deviation/CAPA investigations in technical operations support capacity. Experience managing scientific projects and studies. Known for thorough and efficient deviation/CAPA investigations that resulted in well-written reports.

Skills : MS Office, Forklift Operator, Communication Skills.

• Verified raw materials chemical/packaging, test results, batch yield, and insuring all documents are accounted for and complete.
• Partnered with planning, production, and shipping to facilitate release of GMP products.
• Prepared annual 2004, 2005 FDA reports of GMP products.
• Included inspection of finished goods, stability results, fill weights, process capabilities, testing results, documentation, leaker/damage rates, returns/recalls/complaints.
• Coordinated with Microbiology lab, shipping, salvage, and production.
• Oversaw instrument lab day to day operations.
• Designed database that provided managers immediate access to eight years' worth of data.

Objective : Experienced Quality Assurance Chemist with outstanding knowledge of petrochemical storage and distribution. Comfortable working in a high production team environment where safety standards and quality are critical. Possess well-honed analytical and problem solving skills. Laboratory analytical instruments: GC - Capillary System Density meters UV/VIS Distillation equipment Karl Fisher apparatus pH meter Refractometer ACP apparatus.

Skills : HPLC, HPLC, Quality Assurance, Research, R&D, Visual Basic, Visual Basic, Process Improvement, Management, FTIR, Statistical Analysis.

• Responsible for quality assurance of all petrochemicals inbound and outbound from this terminal.
• Managed all laboratory functions including calibration of equipment, ordering of supplies and housekeeping.
• Performed monthly tank sampling and analysis.
• Worked closely with office staff and terminal attendants to ensure the quality of products received, stored, or transported is maintained.
• Created report to set flags to alert readers of any impurities outside the limits.
• Served as Functional Record Coordinator for the Records Information Management program at the facility.
• Maintained batch and shipment sample retention based on customer needs.

Objective : To acquire a challenging position within an organization that has an inspired team recognized for innovation and industrial leadership; excels in safety, health, and environmental compliance; understands operational excellence and continuous improvement. To acquire a position within a company that continuously exceeds customers' and communities' expectations in customer satisfaction and community relations.

Skills : Management, Project Management, Process Improvement, Personnel Management, Lotus 123, It Project Management.

• Supported global development centers and manufacturing sites in risk management related to chemical handling and processing.
• Developed, communicated, and assisted with the implementation of chemical handling standards and policies.
• Provided leadership and direction that ensures compliance with customer analytical/microbiological test requirements.
• Coordinated with 3rd party labs to fulfill external testing requirements.
• Served as a subject matter expert to provide support during customer and regulatory inspections, reviews and on-site meetings.
• Advised on the internalization of testing operations, as appropriate.
• Rebuilt an effective community relationship which ultimately led to the development of a communication video.

Objective : Responsible for Scheduling and executing audits of plans, data, and reports for accuracy and compliance for regulated studies, Auditing laboratory activities performed by operations for compliance.

Skills : SQF, Lean Manufacturing, Lean Six Sigma, Kaizen, 5S,.

• Trained associates on new FDA procedures to detect HIV and WN Virus at DNA/ RNA level plus the operating of the production line equipment such as Tecan GENESIS, Procleix Target Capture, Procleix HC+, HPLC, and etc.
• Participated in problem-solving using a lean system, root cause analysis tools such as CAPA, 6sigma, 5whys.
• Recognized for being firm on procedures and practices in complying with the lean system, SOPs, GMP, and HSE.
• Protected company's interest from any possible obstruction to the production line before it occurs.
• Created a safeguard strategy to monitor the inventory turnaround time before the raw material outage.
• Utilized Excel to perform equations on gathered data from the finished product.
• Performed micro-test on finished product three times a week.

Headline : An experienced self-motivated and confident individual who has worked in different work environments with individuals at all levels. Detailed oriented and resourceful in completing tasks such as managing laboratory research and sales/customer services.

Skills : Organizational Development, Management Skills, Communication Skills.

• Developed and qualify methods using advanced analytical instruments.
• Maintained analysis capability to meet the production schedule and the needs of the project manager.
• Completed Gauge RR on all methods, and ensure that all are below 5% error, using a complex mathematical algorithm.
• Led 5S implementation throughout the company.
• Used quality control to ensure the accuracy and precision of all analytical results.
• Wrote SOPs, standard operating procedures with great detail to record analysis methods with high repeatability and reproducibility.
• Updated technology by ordering new instruments and transferring valid methods.

Headline : Seeking a Quality Assurance Chemist profession with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.

Skills : Python, R, Java, Javascript, SQL, MongoDB, Machine Learning, Statistical Analysis.

• Routinely used analytical techniques such as HPLC, TC, NIR, and ICP to ensure samples and final products meet internal and external customer specifications.
• Responsible for maintaining, validating, and calibrating them.
• Involved in troubleshooting process upsets and deciding the best avenue to resolve any issues that may arise.
• Trained new employees on Quality Assurance systems, analytical methods, and instrumentation.
• Prepared media and broth for the four types of micro testing that are performed.

Headline : Responsible for Scheduling and executing facility audits of equipment, systems, and processes in compliance with QAU SOPs, Providing, tracking, and closing written audit reports for all auditing activities.

Skills : Lab Experience, Supervisor, Management Skills.

• Managed water treatment program for $30 million facilities consisting of 2 boilers, 1 reboiler, 2 cooling towers, 2 chillers, and 2 water softeners.
• Maintained all instrumentation in the laboratory and calibrated based on an established schedule.
• Worked with operators when product is out-of-specification to determine the cause.
• Interacted with sales and R&D to ensure that product meets the customers' requirements.
• Performed inventory count of all raw materials and finished product and work with the accounting department to explain variances between book and physical count.
• Managed finished product tank farm including daily testing of the product.
• Maintained existing procedures and implement new procedures as necessary.

Headline : Focused, knowledgeable, dedicated scientist and researcher, exemplifying the values of cross-department process improvement, kaizen, and mise en place. Adaptable, resourceful, an intuitive ability to understand and master a wide variety of technical equipment. Energetic, diplomatic, solution-oriented no matter the situation.

Skills : GCMS, Gas Chromatography, Liquid Chromatography, HPLC, HPLC, HPLC, Mass Spectrometry, Mass Spectrometry, Mass Spectrometry.

• Designed an automated gas analysis system that saved 80 man-hours per month by automating gas analyzers in the CO2 lab.
• Forged strategic partnership with European Air Liquide scientists to accelerate compliance with tightening requirements of global customers.
• Upgraded Quality Assurance lab by selecting, purchasing, and setting up new GC/MS to identify and quantitate a variety of critical impurities that could not be detected before, bringing lab into compliance with tightening customer and regulatory requirements.
• Reduced defects cost by $500,000 per year by inventing a foolproof calibrator for the Quality Control analyzers and instruments at carbon dioxide plants across the country.
• Solved a training problem by writing a QC instruction manual and used it to train plant operators.
• Although they had no background in chemistry, they were able to understand the operation of the GCs and integrators.
• Repaired gas chromatographs infield, which saved about $24,000 by reducing down time for each occurrence, compared to the typical response time from the instrument manufacturers.

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Resume of Quality Manager - Pharma

Description

Harpreet is an industrious professional with a strong understanding and comprehensive knowledge of Standard Operating Procedures in the Pharma Industry. She is skilled in lot management, stability review, temperature monitoring, maintenance of quality agreements, the release of products for sale, and product inspection (audits). She supports Key Quality Systems through coordinated administration of the Quality assurance team and is well acquainted with the ISO standards and safety requirements.

Related Categories

• Pharma / Pharmaceutical

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Resume Skills and Keywords for Quality Manager- Pharma

Quality Managers in the Pharmaceutical industry are responsible for improving medical products in accordance with safety guidelines through quality assurance activities and creating audit reports. They are acquainted with the product and manufacturing process, risk assessment, and mitigation to support product development.

Skills required for a Quality Manager role

• Quality Driven Management (QDM)
• Pharmaceutical Compliance
• Project Management 
• Team Management
• Internal Auditing
• Good Manufacturing Practice (GMP) 
• Good Laboratory Practice
• Strong Communication 
• Process Improvement
• Reporting & Documentation

What recruiters look for in a Quality Manager resume: 

• Certified individuals acquainted with the ISO standards and safety requirements.
• Prior experience within the Pharma industry in a management role.
• Ability to identify and resolve quality and production issues.
• Proficiency in performing routine inspections and quality tests.

What can make your Quality Manager resume stand out:

A strong summary that demonstrates your skills, experience, and background in the pharma sector

Industrious professional with a strong understanding and comprehensive knowledge of Standard Operating Procedures in the Pharma Industry including lot management, stability review, temperature monitoring, maintenance of quality agreements, the release of products for sale, and product inspection (audits). Supports Key Quality Systems through coordinated administration of the Quality assurance team. Well acquainted with the ISO standards and safety requirements.

Targeted job description 

• Create, architect, implement, and drive continuous improvement of the global process for all Mankind's products.
• Manage relationships and coordinate with the Regional Business Units including R&D, Supply Chain, Supplier Quality Management, Post-Market Surveillance, and Regulatory Affairs to ensure alignment on strategic initiatives.
• Interface with the Quality Compliance audit team to support audit plans, due diligence plans, and inspection readiness plans.

Related academic background 

• DNB (ENT) from National Board of Examinations |  2017
• M.S (Master of Surgery) ENT from Indira Gandhi Government Medical College, Mumbai | 2014
• M.B.B.S from Govt. Medical College, Bangalore | 2009
• DaVinci Certification for robotic surgery- Seoul, South Korea.

Sample Resume of Quality Manager - Pharma in Text Format

HARPREET KAUR

Quality Manager (Pharma)

9835422656 | [email protected] | Noida, India

EXPERIENCE/INTERNSHIP

Pharma Quality Manager at Mankind Pharma,  Noida | Jul 2021 - Present 

• Serve as the data architect for the implementation of the Product Lifecycle Management (PLM) systems to ensure product information.

Assistant Quality Manager at Mankind Pharma, Noida | Aug 2019 - Jul 2021

• Prepared and implemented quality assurance policies and procedures in alignment with the ISO standards.
• Performed routine inspections and quality tests and recommended improvements.
• Documented quality assurance activities and create audit reports.
• Developed training materials and operating manuals for a better understanding of the manufacturing processes and safety requirements.

Quality and Compliance Role at Sun Pharma, New Delhi | Sep 2018 - Aug 2019

• Coordinated in the Quality assurance team with an understanding of the product standards, and approved samples and testing requirements and protocols to support field operations.
• Ensured safe delivery and quality owned brand products from the vendors.
• Leveraged analysis and reporting on vendors' factories' performance with a feedback loop.
• Actively influenced decision-making and addressed business needs through active engagement with CFT/business partners.
• Assessed and resolved product and inspection issues.

Intern at Sun Pharma | Jan 2018 - Aug 2018

CERTIFICATIONS

Pharmaceutical Quality Manager from Institute of Good Manufacturing Practices in India|2018

Master of Business Administration in Total Quality Management from Amity University, Noida | 2018

B. Pharma from Jamia Hamdard University, New Delhi | 2016

Senior Secondary from Delhi Public School | 2012

SKILLS (TECHNOLOGY/FUNCTIONAL)

Quality Driven Management (QDM) | Pharmaceutical Compliance | Project Management Team Management | Internal Auditing | Good Manufacturing Practice (GMP) | CAPA | Good Laboratory Practice | Strong Communication Process Improvement | Reporting & Documentation

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QA Associate Resume Sample

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Work Experience

• Proactively handling all quality compliance effectively
• Product quality reviews
• UK and/or EU experience
• GMP and GDP legislation
• Responsible for batch review and coordination of product release activities at Shire Contract Manufacturing Organizations (CMO) for both commercial Cinrzye, clinical Cinryze, associated by products and Legacy Baxalta products
• Responsible for the continuous operation of the facility’s mechanical systems, monitoring systems and equipment. Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. autoclaves, dishwashers, depyrogenation oven), as directed by QA Manager
• Knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA
• Work prioritization skills
• Keep comprehensive and accurate records in a multi-faceted environment
• Well-developed consultation and negotiation skills
• Write and route operating procedures, manufacturing documents, and other QA controlled documents in QUMAS
• Interact with internal customers
• Support quality systems
• Issue/review controlled forms
• Scan executed batch records and maintain electronic files for future reference as necessary
• File executed quality documentation in the records room
• Enter data into multiple systems to ensure compliance with regulations
• Perform walk-throughs, changeovers, and QA on the floor inspections
• Provide project support for QA
• Serve as customer proxy for projects as assigned
• Create and revise job aides
• Review and approve executed GMP batch documentation
• Generate, review, and apply product labels
• Serve as MRB coordinator
• Serve as QA resource for cleaning verification/validation

Professional Skills

• Attention to detail, good organizational and interpersonal skills, and problem solving skills
• Positive interaction skills, attention to detail, and organizational skills
• Strong analytical skills. Ability to document business requirements and assist in developing reporting / data mining standards
• Excellent documentation and handwriting skills
• Excellent technical oral and written communication skills are required
• Detail oriented with excellent verbal communication skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)

How to write QA Associate Resume

QA Associate role is responsible for organizational, reporting, database, technical, gmp, word, documentation, finance, training, integration. To write great resume for qa associate job, your resume must include:

• Your contact information
• Work experience
• Skill listing

Contact Information For QA Associate Resume

The section contact information is important in your qa associate resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

• First and last name
• Telephone number

Work Experience in Your QA Associate Resume

The section work experience is an essential part of your qa associate resume. It’s the one thing the recruiter really cares about and pays the most attention to. This section, however, is not just a list of your previous qa associate responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qa associate position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative QA Associate resume experience can include:

• Facilitating and coaching skills
• Communicating effectively, verbally and in writing, with all internal and external clients
• Quality experience, preferably including manufacturing operations, API and drug product release, QP release, process validation
• Demonstrated experience working with and preparing SOPs
• Prior experience working in a cGMP regulated environment, preferably in a pharmaceutical/biotech company
• Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations

Education on a QA Associate Resume

Make sure to make education a priority on your qa associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qa associate experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

• School you graduated from
• Major/ minor
• Year of graduation
• Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in QA Associate Resume

When listing skills on your qa associate resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical qa associate skills:

• Good, clear communication skills with strong attention to detail
• Good time managements skills
• Possess good communication skills both written and verbally
• Strong Computer skills in spreadsheet and word processing applications is required
• Sound decision-making, technical and problem solving skills
• Expert technical writing and problem solving skills

List of Typical Experience For a QA Associate Resume

Experience for senior qa associate resume.

• Strong accuracy and attention to detail. Ability to multi-task, meeting tight deadlines in a fast paced environment
• Positive role model. Responds positively and energetically to changing circumstances and priorities and fosters collaborative relationships across groups
• Experience in auditing in a GMP environment
• Possesses a good understanding of current quality control GMP regulations
• Experience in pharmaceutical product development
• Provide validation / preventative maintenance support for critical equipment and write associated protocols
• Ensures that all documentation related to bulk and finished product release is collected and compiled prior to release
• Ensures that clients are forwarded scanned copies of necessary documentation prior to release of bulk and finished products or for approval of change controls
• Experience with SAP (an asset)

Experience For QA Associate / Batch Record Reviewer Resume

• Strong knowledge of GMP’s and their application
• Change management and CAPA management experience
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
• Promotes team work and good communication
• Experience in GMP regulated industry
• Previous QMS process design, implementation, management and utilization experience

Experience For Clinical Lab QA Associate Resume

• Represents QA in change control, standardization and consolidation activities to ensure implementation occurs in a state of compliance. (no adverse impact)
• Quality Assurance experience in an FDA or GMP regulated environment
• Five or more years of experience in the pharmaceutical quality function
• Experience in pharmaceutical product development and expectations for early phase clinical trials
• Checking the monitoring and control of the manufacturing environment. Support in checking and ensuring proper plant hygiene
• Ensuring continuity among corporate and divisional work teams by documenting and communicating actions, irregularities and continuing needs

Experience For QA Associate, Document Control Resume

• Leading GxP training sessions and hands-on training to support users in learning workflows for our electronic GxP data systems at deployment
• Ensuring the proper routing of documents for approval and training
• Providing training and guidance to staff regarding the use of the system
• Monitoring and reporting of quality activity ensuring management is informed in a timely manner of changes/trends that could affect SSPs quality system
• Participating in new hire interviews; facilitating hiring decision
• Producing and assessing/trending metrics from quality issues (audits, complaints, non-conformances etc)
• Checking and ensuring adequate control and monitoring of storage conditions for materials and products
• Working on special projects relating to the Quality Department’s Continuous Improvement Plan
• Managing the departments, roles, and training courses setup and maintenance

Experience For QA Associate Compliance Resume

• Approving and monitoring the performance of suppliers of materials
• Sampling of intermediate products within the manufacturing process
• Understanding and working knowledge of Quality Management Systems
• Manufacturing, Packaging, and Laboratories. Initiate and participate in investigations and CAPAs
• Reporting of SSPs audit performance and results to executive leadership corporate RAQA
• Working knowledge of GMP requirements and associated guidelines
• Manufacturing and quality control operations
• Maintaining external/internal audit observation database and track observation response

Experience For QA Associate / QA Specialist Resume

• Tracking to closure of corrective and preventive actions from client audit, regulatory inspections, complaints, non-conformances and deviations
• Reviewing and approval of documentation associated with qualification exercise
• Performing QA review of source documents, case report forms (CRFs), offsite shipments and other reports for accuracy as needed
• Testing and inspection of product, as required by SOP and Finished Product Specification
• Working knowledge of US and EU Regulations and associated guidelines
• Training coordinator for QA group
• Training in QA, cGMP or an equivalent quality system

Experience For QA Associate, Data Reviewer Resume

• Working in A DevOps model
• Motivating financial remuneration and nonfinancial benefits
• Working knowledge of nutrition (i.e. Calories, Protein, Fiber, etc.)
• Working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer
• Liaise with customers to determine the impact on the Marketing Authorisation of any deviation raised during the manufacturing or testing processes
• Responsible for clean room changeover activities such as performing Environmental monitoring, checking room logs, equipment calibration and trash
• Provide training and coaching to manufacturing staff as needed

Experience For Marketing Optimization Control / QA Associate Resume

• Assists with the initial new employee training and maintaining employee training folders
• Become familiar with targeted list development for all ongoing Consumer Bank Marketing campaigns
• Review SAS and Unix code and modifications for ongoing marketing campaigns to verify accuracy and efficacy of changes
• Assist with development, testing, code review, and ongoing maintenance of automated campaign code
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Fundamental working knowledge of laboratory testing equipment and product transportation operations, pipeline locations and product specifications

Experience For Tax Conversion QA Associate Resume

• Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance’s, FDA regulations, etc
• Maintain logs of raw material usages and incoming/outgoing documents to/from QA
• Perform weekly and monthly metrics and trending reports for manufacturing
• Support product development teams for API/drug substance, drug product and/or labeling/packaging operations
• Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging, taking action to overcome likely obstacles

Experience For Contract QA Associate Resume

• Provide mentoring, assistance and training to core quality management system processes where required
• Ensure SSP maintains an exemplary record of compliance and commitment to relevant quality standards by working with, and influencing all departments
• Runs tests and retests as necessary, executing test scripts in area ofaccountability, reporting on test activities and results in accordance with project plans
• Assists in collecting and analyzing production samples to evaluate quality
• Maintain appropriate records of manufacturing/packaging for future reference
• Assist in troubleshooting course communications within our Learning Management System (LMS)
• Assist in conducting GMP training for the site for new employees

List of Typical Skills For a QA Associate Resume

Skills for senior qa associate resume.

• Demonstrated good judgment and decision-making experience
• Excellent knowledge of local and international Good Manufacturing Practices (GMP) and
• Exceptional attention to detail and competent with data entry/computer skills
• Approximately 3-5 years of experience in Food Safety Quality Assurance (FSQA) in industry; or exceptionally strong academic record or internship
• Demonstrated experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations
• Experience in a strongly regulated or GMP environment
• Liaison between QA and client to effectively communicate with clients with regards to executed batch records and review status

Skills For QA Associate / Batch Record Reviewer Resume

• Performs technical reviews and interprets data for accuracy of equipment/process performance for completed validations/revalidations
• Bachelors in Chemistry or Biology (or related field) with 4 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or,
• Masters in Chemistry or Biology (or related field) with 3 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience; or,
• PhD in Chemistry or Biology (or related field) with 2 years of Pharmaceutical Quality experience and/or cGMP Laboratory experience
• Advanced computer skills, specifically in Microsoft Word, Excel, and Power Point
• Demonstrated experience in clinical safety laboratory management
• Organizational, leadership and project management skills

Skills For Clinical Lab QA Associate Resume

• Significant experience in a QA position and experience of working in a customer facing role is essential
• Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices
• Working directly with Bioclinica development teams to ensure the accuracy and consistency of system development and validation deliverables
• Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, Vendor management
• Experience in conducting and/or supporting customer/vendor audits
• Experience in implementing and maintaining quality systems
• Experience of working in clinical trials quality/packaging/distribution (IMPs, clinical trials)

Skills For QA Associate, Document Control Resume

• Experience in supporting manufacturing operations and batch record review is highly desirable
• Previous quality control or claims processing experience
• Advanced skill in technical writing
• Good programming knowledge in c, c++, Java
• Demonstrated ability to work independently while staying connected with key stakeholders
• Experience in change management and deviation resolution including CAPA systems

Skills For QA Associate Compliance Resume

• Review batch records, deviations, documents, and validation protocols ensuring GMP/FDA compliance
• Experience in Pharmaceuticals (Steriles or biotech manufacturing environment)
• Help provide quality oversight to production activities, including validation activities
• Experience in the development of training material & facilitation
• Strong attention to detail and accurate record keeping

Skills For QA Associate / QA Specialist Resume

• Review of manufacturing batch records, executed validation review, Maximo WO’s, and logbooks
• Possesses a good understanding of current quality assurance GMP regulations
• Experience working on large/medium sized projects ideally in Java EE with Payments Domain
• Sound working experience with
• Suggests and implements solutions balancing good science, product quality impact, GMP compliance, cost and business needs

Skills For QA Associate, Data Reviewer Resume

• Administrative experience, supporting multiple people
• Experience working in a QA department in GxP regulated facility
• Experience drafting SOPs and instructional materials
• Experience of TestComplete, Perforce, GIT LI-AK1
• Experienced with continuous improvement techniques
• Responsible for ensuring cleaning processes are validated to required standards
• Biotechnology, Pharmaceutical industry experience
• Contract Manufacturer Batch Record, validation documentation, general documentation, and deviation / investigation review and approval

Skills For Marketing Optimization Control / QA Associate Resume

• GMP experience
• Good motivator of personnel
• Good team player with a can-do attitude
• Provide validation/preventative maintenance support for critical equipment
• Technical Certification with 0-2 years of related experience
• Food industry experience, ideally in a Regulatory or Quality capacity
• Quality Control/Assurance GMP experience in a related field

Skills For Tax Conversion QA Associate Resume

• Experience with bath record review, approval and release, MFG line approvals, CAPAs
• Experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
• GMP or regulated environment experience is preferable
• Work experience with quality assurance systems and regulations
• Experience with co-ordination of internal and external audits
• Preferably, one to two years experience in a pharmaceutical QA/QC environment
• Very good knowledge in OOPS & SQL
• Relevant professional experience conducting QA audits in compliance with GCP and ICH
• Experience in pharmaceutical industry

Skills For Contract QA Associate Resume

• Pharmaceutical Quality Assurance experience, including the ability to identify and resolve compliance issues
• Familiarization with oral solid dose manufacturing qualification and quality
• Experience in a Quality Assurance role in the pharmaceutical industry
• Experience with the qualification of facilities, utilities, equipment and processes
• Ideally 5+ years’ experience in the Medical Device Quality Systems
• Monitors performance of quality control systems to ensure effectiveness and efficiency
• 3D / 2D CAD software experience
• Manage product releases on a daily basis as requested in the priority list

List of Typical Responsibilities For a QA Associate Resume

Responsibilities for senior qa associate resume.

• Coordinates with CMO’s to obtain data required to generate the APQR’s. Reviews the data received and generates the final APQR for review and approval by QA management and Qualified person
• Initiation of deviation records in Shire’s Trackwise for major and critical deviations occurring at CMO’s or manufacturing plants for chosen product
• An exceptional communicator. To us, this means adaptable and personable writing skills, confident and articulate verbal skills, and active listening
• Proven customer service experience including phone interaction
• Work effectively in a small team environment
• Demonstrate sound decision making relating to quality issues
• Approve for release (or reject) packaged goods and manufactured products
• Quality Assurance QA experience within the food / pharmaceutical / dietary supplement industry
• Experience in a GMP environment required

Responsibilities For QA Associate / Batch Record Reviewer Resume

• Excellent attendance and ability to work overtime required
• Conducts on- and off- site audits, vendor qualifications and re-assessments, and computerized system validations (i.e. 21 CFR Part 11 compliance)
• Experience with GMP and/or other directives is an asset
• A good knowledge of GMP
• Review and approve final batch records prior to product release
• Review and approval of validation protocols and reports
• Food Safety Quality Assurance (FSQA) experience
• Liaising with manufacturing departments to manage timely review and completion of batch records

Responsibilities For Clinical Lab QA Associate Resume

• Maintaining the QA files/records for Customer audits
• Handling of Finished Product COA to customers
• Handling of Finished Product Releases via the Oracle System
• Administrate the activities for complaints processing (assessment, investigation, tracking, review, approval, escalation, trending)
• Ensure that all incoming materials and outgoing finished products comply with internal and FDA specifications
• Administrate the activities for Annual Product Quality Review (report writing, compilation, and tracking)

Responsibilities For QA Associate, Document Control Resume

• Responsible for routing and tracking documents with document control database
• Manage and audit proper use of the code version control tool used for marketing campaign support
• Manage multiple SFTP connections, for secure transfer of marketing files from Chase to approved Vendors
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Provision of appropriate GMP/GDP training to appropriate job functions
• Natural aptitude for working with computer applications
• Assist in the development and maintenance of quality procedures and recording

Responsibilities For QA Associate Compliance Resume

• Function as QA auditor for in-process checks during production
• Route manufacturing and quality documentation to management for consensus and approval
• Manage physical inventory of documents control including documentation in the file room and electronic database of documentation
• Conduct daily and periodic audits and review Alaska Medicaid fiscal agent operations including but not limited to
• Responsible for review and approval of Manufacturing documents
• Responsible for maintaining timely and accurate ORACLE inventory transactions

Responsibilities For QA Associate / QA Specialist Resume

• Perform monthly material expiration reports throughout manufacturing
• Administrate and coordinate the activities for regulatory inspections including management of the regulatory responses
• Administrate the activities for the Vendor Assurance Program (tracking and contract renewal)
• Serve as subject matter experts on aforementioned activities providing technical guidance to team/local functions
• Lead auditor for internal (head office and branch), and external supplier audits including OEMs

Responsibilities For QA Associate, Data Reviewer Resume

• SME representing Quality for Merger & Acquisition activities
• Responsible for partnering with areas of business to ensure activities are in compliance with Quality System
• Provide mentoring and assistance to junior members of Quality team
• Knowledge and understanding of applicable external regulatory standards
• Assists in communicating quality control information to all relevant organizational departments, outside vendors, or contractors

Responsibilities For Marketing Optimization Control / QA Associate Resume

• Assists in communicating quality control and analytical procedures to staff
• Assists in analyzing quality control test results and provides feedback and interpretations to production management or staff
• Produces reports regarding non-conformance of products or processes, daily production quality, root cause analyses, or quality trends
• Identifies and reports deviations from established standards in the manufacturing process
• Proficient with Sam’s Club systems, policies, and procedures that are related to servicing members
• Very familiar with FSMA (Food Safety Modernization Act), HAACP, SQF, and other FDA regulations pertaining to food industry
• Monitor project status with regular reporting of supplies metrics
• Review and approve technical reports and protocols originating in other departments
• Lead specific aspects of a project and guide solutions for difficult problems identifying best solutions based on project requirements

Responsibilities For Tax Conversion QA Associate Resume

• Provide on the floor QA support and perform QA Operations activities (batch record review, documentation review, product sampling, oversight, etc.)
• Prepares temperature sensitive filled product for shipment to commercial partners as well as contract manufacturers per SOP’s
• Support team as needed for the controls and quality standards for transportation and temperature control management activities
• Support team as needed for the quality oversight of all product quality holds and field actions related to transportation within EMEA
• Implement quality program for evaluating and monitoring the company’s quality and transportation process capabilities against company and industry standards and regulatory expectations
• Medical device, Pharmaceutical DC or Transport Q&C management

Responsibilities For Contract QA Associate Resume

• Recommend ongoing process improvements to the campaign list management team, especially as they pertain to improved efficiency and reduced opportunity for error
• Responsible for the execution of Quality Management System and Compliance elements such as documentation, record, metrics and KPIs, dashboard, training, audit schedule and follow-up
• Works crossfunctionally to assess impact for potential deviations and assist in identifying if an investigation is required
• Other assignments as needed within the scope of QA Associate training curriculum
• Responsible for the quality oversight of all product quality
• Recommend SOP and batch record changes as needed
• Review proposed SOP revisions and provide feedback to management

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