Qc Analyst, Car-t Manufacturing
il y a 2 semaines
The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
**Responsibilities**:
- Responsible for the completion of QC testing related to the manufacturing of autologous CAR- T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
- Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
- 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.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
**Key Relationships**:
Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations and Analytical/Process Development.
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YOUNG GRADUATES
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