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Senior Associate, Quality Assurance
2 months ago
As a Senior Associate, Quality Assurance, you will be responsible for performing QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. This role requires a strong understanding of cGMP/GLP and analytical instrumentation.
Key Responsibilities- Perform QA review of testing records, including raw materials, in-process and finished products, stability samples, and non-routine sample analyses.
- Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system.
- Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities.
- Support any regulatory inspections or internal/external audits.
- Conduct, document and follow up on OOS and OOT and Out of Calibration investigations.
- Conduct, document and follow up on Lab Events.
- Review calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment).
- Review IQ/OQ and PQ protocols for analytical instruments.
- Maintain laboratory in cGMP compliance and conduct inspections and internal audits.
- Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
- B.S. or equivalent experience.
- Excellent oral, written and interpersonal communication skills.
- Ability to follow specific instruction (i.e. written SOPs).
- Minimum 5-7 years of related experience.
- Working knowledge of cGMP/GLP.
- Fundamental knowledge of chemical principles and analytical instrumentation.
- Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.).
- Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting).
- Competent computer skills including Microsoft Office and instrumentation control software programs.
- Experience with qualitative and quantitative analysis using good analytical laboratory practices.
This role requires working in a laboratory setting with exposure to non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials. The ability to work in a fast-paced environment with multiple priorities is essential.
BenefitsAs a Senior Associate, Quality Assurance, you will be eligible for a competitive salary range of $98,000 to $119,500, as well as a comprehensive benefits package, including medical, dental and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and the employee assistance program.
