Piper Companies is seeking a QC Analyst to perform QC testing for clinical trials and commercial manufacturing for a Global Pharmaceutical Company in Raritan, NJ.
Responsibilities for the QC Analyst included:
- Responsible for the QC testing related to manufacturing
- Ensure testing is complete and in compliance with all standards and regulations
- Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems (LIMS) for execution and documentation of testing.
- Create, review and approve relevant QC documents, SOP’s and WI’s.
Requirements for the QC Analyst include:
- Experience in a Quality Control setting is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
- Knowledge of Good Tissue Practices is required.
- Detailed knowledge of CAR-T QC test methods and related equipment is preferred
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- This position may require up to 10% domestic or international travel as business demands.
Compensation for the QC Analyst include:
- Pay rate is commensurate with experience