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Sr. Quality Assurance Specialist

1 month ago


Billerica, United States EPM Scientific Full time

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