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Manager, quality control laboratory skills for your resume and career
15 manager, quality control laboratory skills for your resume and career
1. 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.
- Initiated environmental monitoring programs, ensuring compliance with proposed FDA requirements.
- Authored and reviewed data integrity documents for compliance with FDA requirements.
2. 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.
- Manage a GMP chemistry and microbiology QC laboratory comprised of 20 chemists/microbiologists and 5 senior chemists.
- Complied with GLP and GMP guidelines to ensure accuracy and completeness of data for release.
3. Lab Equipment
- Upgraded software in lab equipment to facilitate transfer of information from local lab equipment to network capable information systems.
- Managed lab technicians to insure that all lab equipment was maintained and calibrated.
4. CAPA
- Performed investigational writing, CAPA setting and implementation using TrackWise computer system.
- Conducted laboratory investigations (utilizing LIMS and Trackwise), and implemented CAPA's.
5. Product Quality
Product quality is the basic element of a business. It means to add features in a product or service in such a way that it meets the needs and wants of the customers. Enhancing the product quality also means improve the goods from any existing defects to ensure customer satisfaction.
- Managed day-to-day manufacturing/production support in USA and Malaysia for reducing costs and continuous improvement in product quality.
- Partner with operations to improve process and product quality.
6. QC Laboratory
- Managed QC laboratory operations (chemistry and microbiology).
- Led QC laboratory to develop, validate, and execute assays for microbial quality control.
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A LIMS - Laboratory Information Management System is a software solution to improve laboratory productivity and efficiency with modern support of laboratory operations to address the challenges of data and sample management, automation, and regulation of laboratories from around the world and thus maintaining workflows and standardized testing and reporting procedures.
- Major role in implementation of new LIMS system globally- one site at a time.
- Optimized workflow by eliminating manually written QC records and using the LIMS system and eliminating unnecessary tests.
8. OOs
- Investigated failing results and generated out of specification (OOS) reports using MS Office programs for the Quality Assurance Unit.
- Succeeded in the investigations of several OOS (out of specifications) results.
9. Quality System
A quality system is an organizational structure that helps management, procedures, and processes. The quality system helps the company to achieve its goals by following the right procedures. The quality system is usually documented and is based around a manual that defines and controls the system.
- Collaborated with Materials Management to implement a lean quality system in the laboratory.
- Lead the establishment and improvement in Quality System activities, as part of continuous improvement efforts.
10. OSHA
- Trained lab assistants in procedures of the lab and completed required EPA, DNR and OSHA regulatory reports.
- Developed and implemented company wide Hazard Communication program, OSHA compliance guidelines.
11. USP
USP, acronym for Unіԛuе Sеllіng Proposition, Unіԛuе Sеllіng Pоіnt or Unіԛuе Value Prороѕіtіоn, іѕ a fасtоr thаt dіѕtіnguіѕhеѕ a product аnd/оr ѕеrvісе from the rеѕt of thе competing brаndѕ іn the market. It ѕummаrіzеѕ thе еѕѕеnсе оf a buѕіnеѕѕ аnd therefore ѕеrvеѕ as thе guіdіng рrіnсірlе for аll mаrkеtіng еffоrtѕ.
- Worked diligently to ensure USP harmonization methods were validated in a timely fashion.
- Designed experiments and implemented USP Suitability and Preservative Efficacy Testing; worked with R&D to assist formula improvement.
12. Regulatory Agencies
A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.
- Developed and implemented corporate competency assessment program and proficiency testing program resulting in enhanced compliance with Federal and State regulatory agencies.
- Schedule and control inspection activities and to attain requirements as specified by product and package specifications, and regulatory agencies.
13. ICH
- Validated two methods that meet ICH requirements.
14. HPLC
- Key Achievements Developed approximately twenty HPLC, GC and wet chemistry methods in support of commercial product release.
- Performed instrumentation troubleshooting and repairs on quality control instrumentation specifically HPLC, GC and ELSD.
15. R
R is a free software environment and a language used by programmers for statistical computing. The R programming language is famously used for data analysis by data scientists.
- Compete National Board Data reports A and R code stamps Assumed managerial duties upon reassignment of the Manager
- Performed NBIC R Stamp inspection for approval and filing to the State Board.
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List of manager, quality control laboratory skills to add to your resume

The most important skills for a manager, quality control laboratory resume and required skills for a manager, quality control laboratory to have include:
- FDA
- GMP
- Lab Equipment
- CAPA
- Product Quality
- QC Laboratory
- Lims
- OOs
- Quality System
- OSHA
- USP
- Regulatory Agencies
- ICH
- HPLC
- R
- Laboratory Procedures
- Analytical Methods
- Lean Six Sigma
- Direct Reports
- GC
- GLP
- Sigma
- Method Development
- Compliance Issues
- Test Methods
- Qc Testing
- Stability Program
- Lab Operations
- Microbiology Laboratory
- API
- Laboratory Quality
- Environmental Monitoring
- Test Results
- CFR
- Process Control
- Proficiency Testing
- Internal Audit
- Laboratory Investigations
- IQ/OQ/PQ
- Cleaning Validation
- Method Validation
- Analytical Equipment
- TrackWise
- HACCP
- ASTM
Updated January 8, 2025