Cell Therapy QA Specialist
3 weeks ago
We are seeking a highly skilled Cell Therapy QA Specialist to join our Quality Operations team based in Raritan, New Jersey.
Key Responsibilities- Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits.
- Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues.
- Review, revise, or draft Standard Operating Procedures (SOPs).
- Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised.
- Support material release in SAP for In-house reagents.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
- Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
- Utilize multiple electronic quality systems, batch records and SAP.
- Bachelors degree required in Life Sciences or Engineering.
- 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
- Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
- Experience with quality support in clinical manufacture is preferred.
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Cell Therapy Production Specialist
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Quality Assurance Document Control Lead
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Warehouse Operations Manager
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QC Supervisor
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Raritan, United States Legend Biotech USA, Inc. Full timeThe CAR-T Operations Manager is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in a s Operations Manager, Operations, Manager, Operation, Project Management, Manufacturing
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Senior Commercial Coordinator
3 weeks ago
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