Sr. QC Analyst
Responsibilities of the Sr. QC Analyst:
- Review routine/non-routine data from in-process, final product, raw material, environmental monitoring samples in accordance with Standard Operating Procedure.
- Responsible for protocol and report generation, as required.
- Perform sample management such as receipt, inventory, tracking.
- Coordinate shipment of samples to contract testing laboratories, as required.
- Trend data and compilate trend reports and ensure data reporting tools are up to date.
- Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- Update QC SOP’s to ensure compliance to appropriate regulations.
- Responsible for change controls, OOS and deviations related to QC Operations, including investigations, as required.
- Work closely with internal and external QC teams to ensure data is completed and reviewed to support timelines and goals.
Requirements of the Sr. QC Analyst:
- Bachelor’s degree in biology, chemistry or other life science and at least 5-8 years of relevant industry experience in Quality Control in a Pharmaceutical/Biotech GMP environment.
- Working knowledge of current Good Laboratory Practices (GLP – 21 CFR Part58), Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.