The QA Release Specialist is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes paper/electronic batch record reviews related to the manufacturing of viral vector and autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Job duties are performed within a team according to an assigned, production shift schedule.
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Major Responsibilities:
- Reviews documentation for all manufacturing activity execution in accordance with good documentation practices.
- Independently executes paper/electronic batch record review associated with commercial, development, and engineering production.
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
- Implements appropriate corrective and preventive actions by investigating non-conformances in a timely manner.
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
show more
The QA Release Specialist is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes paper/electronic batch record reviews related to the manufacturing of viral vector and autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Job duties are performed within a team according to an assigned, production shift schedule.
Major Responsibilities:
- Reviews documentation for all manufacturing activity execution in accordance with good documentation practices.
- Independently executes paper/electronic batch record review associated with commercial, development, and engineering production.
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
...
- Implements appropriate corrective and preventive actions by investigating non-conformances in a timely manner.
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
show more