19 Jan
QC Compliance Specialist
Vacancy expired!
- 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.
- 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
- 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
Vacancy expired!