Cell Therapy Quality Assurance Specialist
4 weeks ago
We are seeking a highly skilled Cell Therapy Quality Assurance Specialist to join our Quality team based in Raritan, NJ.
The successful candidate will be responsible for performing quality control testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Key Responsibilities- Perform quality control testing of raw materials, in-process, and final product samples submitted to the QC laboratories.
- Ensure testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
- Work with the Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to the cGMP facility.
- 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, SOPs, and WI's.
- Bachelor's Degree in Science, Engineering, or equivalent technical discipline.
- Minimum of 1 year of relevant work experience, preferably within a biological and/or pharmaceutical industry.
- 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.
- Excellent written and oral communication skills are required.
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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