Senior Associate, Quality Assurance

2 days ago

Woburn, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

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.
Requirements
  • 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.
Work Environment

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.

Compensation and Benefits

The compensation and benefits for this role are competitive and include a base salary range of $98,000 to $119,500, as well as eligibility for an Annual Performance Bonus Plan. Employees also receive various paid time off benefits, including vacation time and sick time.

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