Quality Control Compliance Specialist / QC Data Reviewer

  • Location: Cambridge, MA
  • Contract Length: 12 Months (Expected to extend based on performance)
  • Compensation: Up to $52-53 an hour depending on experience
  • Benefits: Real Staffing offers medical dental, vision, 401K, voluntary life insurance, short term/long term disability.

Job Description

A global Biopharmaceutical company is looking for a talented QC Compliance Specialist to join their team. Under the direction of the Quality Control Management, the QC Compliance Specialist will be responsible for ensuring and enforcing group compliance to all laboratory, documentation, procedural and regulatory requirements. The QC Compliance Specialist will also be responsible for supporting various analysts in QC documentation roles.

Key Responsibilities:

  • Responsible for all aspects of laboratory data review (technical and compliance), authoring laboratory investigations and certificates of analysis
  • Serve as the QC lead for data integrity projects
  • Assist in ensuring 100% inspection readiness
  • Develop, drive and maintain KPI’s and metrics for the QC lab
  • Responsible for trending OOS, OOT and invalids and implementing process improvements
  • Monitor and ensure timely closure of all laboratory investigations, OOS, OOT, invalids and CAPA’s
  • Monitor and ensure all deliverables for batch release and stability are meet
  • Review investigations, specifications and other GMP documentation

Key Qualifications

  • BS/ MS degree in the life or physical sciences with a preference for a concentration in microbiology, analytical chemistry or pharmaceutical chemistry
  • At least 3 years’ experience working in a GMP laboratory
  • Thorough understanding of cGMP’s and good documentation practices
  • Preferred: Experience with Waters Empower Software and TrackWise preferred

Sthree US is acting as an Employment Business in relation to this vacancy.

– provided by DiceTracking



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