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Quality assurance scientist skills for your resume and career
15 quality assurance scientist skills for your resume and career
1. GMP
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.
- Audit GMP, GLP, QC document reports, review and revised SOP and protocols to comply with FDA regulatory requirements.
- Performed Validation following GMP Guidelines, while ensuring high level of compliance to FDA, NSAI, and ISO 13485.
2. FDA
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.
- Reviewed technical documents for validation process following FDA guidelines.
- Maintained documentation required by FDA.
3. ISO
- Help in the validation and qualification of the ISO 7 room for SUS2.
- Supported Division, Corporate and ISO audits.
4. Data Analysis
- Performed data analysis, provided scientific interpretation of the testing results, and recommended corrective actions as applicable.
- Performed data analysis, identified trends and issues, evaluated and provided recommended solutions for issues detected.
5. Microbiology
- Assisted with equipment qualifications in a newly renovated Microbiology Laboratory.
- Lead change control for Microbiology product Standard Operating Procedures.
6. CAPA
- Perform Investigation, risk and gap analysis / assessment using regulatory guidance and standards to support CAPA projects.
- Lead Root Cause Investigations for alert/action level excursions, insure CAPA identification and escalate to management for review.
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Test methods are the steps in which thorough testing is conducted in a laboratory setting.
- Assist in the development and validation of test methods.
- Initiate change controls for revisions to test methods.
8. Analytical Methods
An analytical method is a method used to determine the chemical or physical property of a substance. It is a procedure to determine the relationship between different variables. This method can be conducted by combining scientific methods with any kind of formal process to solve a problem or prove a fact.
- Identified quality problems and evaluate analytical methods and procedures to determine how they might be improve and make recommendations for improvement.
- Performed initial validation for newly developed analytical method assay protocol to test VHP concentration during packaging of experimental medical product.
9. Lab Equipment
- Be capable of troubleshooting and fixing lab equipment.
- Perfected micro-bacterial analyses and the use of the lab equipment such as the HPLC, GC, GCMS, IR etc.
10. CFR
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.
- Provide regulatory support on CFR 21 and CFR 40 to domestic, international sales teams and R&D.
- Initiated a Stability program for all Cosmetics adhering to pertinent CFR regulations and site specific qualities.
11. Troubleshoot
Troubleshooting is the process of analyzing and fixing any kind of problem in a system or a machine. Troubleshooting is the detailed yet quick search in the system for the main source of an issue and solving it.
- Develop, evaluate and troubleshoot testing methods in support of QC Laboratory, other Pfizer groups and Pfizer subsidiaries.
- Assisted teammates troubleshoot instrument failures and get system back to working conditions.
12. Test Procedures
Test procedure i defined as a tool for conducting an experiment to analyze or observe the specifications of a process or application.
- Record test procedures and results, numerical and graphical data for engineer and management review.
- Performed and investigated studies to modify and correct test procedures.
13. HPLC
- Utilized variety of scientific techniques including HPLC separation techniques, GC, IR and refractive index.
- Conduct tests using medication delivery (HPLC) to determine delivery of finished product.
14. Technical Reports
Technical reports are a type of document that is used to indicate either the progress, result, or process of scientific research or the state of problems occurring within such research. A technical report may also showcase the report's overall conclusion and may also include recommendations. This kind of report does not require a peer review and isn't published officially but distributed within the organizations where it was formed.
- Communicated results with supervisors, QA lab and production staff and wrote technical reports.
- Audit data as part of technical reports to management.
15. Quality Standards
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.
- Maintain documentation and revise quality standards as needed.
- Helped maintain quality standards for equipment testing, diagnosis, and repair after staff reduction from 5 people to 3 people.
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Professor, Harding University
A gap year usually implies finding work as a research technician before applying to graduate or professional school. If this is the case, one question that employers and graduate programs have about their applicants are about their fitness: can they withstand the rigor at the next level? A recent graduate needs to show evidence that they are responsible and timely. The gap year should be filled with activities that show this.
List of quality assurance scientist skills to add to your resume

The most important skills for a quality assurance scientist resume and required skills for a quality assurance scientist to have include:
- GMP
- FDA
- ISO
- Data Analysis
- Microbiology
- CAPA
- Test Methods
- Analytical Methods
- Lab Equipment
- CFR
- Troubleshoot
- Test Procedures
- HPLC
- Technical Reports
- Quality Standards
- Medical Devices
- Technical Support
- OOs
- R
- Quality System
- Data Review
- Test Results
- Product Quality
- Lims
- GC
- Stability Studies
- GLP
- ICH
- Environmental Monitoring
- UV/Vis
- Laboratory Instruments
- Investigation Reports
- Immunoassay
- FTIR
- Laboratory Investigations
- Method Validation
- Internal Audit
- Wet Chemistry
- Analytical Data
- IQ/OQ/PQ
- Qc Testing
- PCR
- Test Data
- Customer Complaints
- Method Development
- TrackWise
- Pipettes
Updated January 8, 2025