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Sr. Quality Assurance Specialist
1 month ago
Title: Sr. QA Specialist (QA for QC)
Location: Billerica, MA
A leading pharmaceutical company is seeking a candidate with a strong QC chemistry background to join their team as a Sr. QA Specialist. The Sr. Specialist will primarily be responsible for providing thorough QA review of QC data and providing QA input for raw materials, stability, and in-process/finished products.
Responsibilities:
- QC testing data review – raw materials and stability
- QC batch record review, lot disposition activities
- Regulatory inspections/audit support
- Conduct and document OOS/T/C investigations
- Review validation documents (IQ, OQ, PQ) for analytical chemistry equipment
- Monitor and evaluate QC systems and equipment, revise any relevant GMP documentation
Qualifications
- B.S. in relevant field with 5-7 years of relevant experience
- Strong background with analytical and wet chemistry: HPLC, UV/Vis, pH Meter, Karl Fischer, etc.
- MUST be authorized to work in the US without sponsorship
If this opportunity sounds interesting, please don’t hesitate to apply