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Quality Assurance Associate III (Qualification Validation), CAR-T Manufacturing
Requisition ID: 9147180418
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate III (Qualification Validation), CAR-T Manufacturing. The position will be located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Quality Assurance Associate III (Qualification Validation), CAR-T Manufacturing is responsible for quality oversight of qualification and validation activities related to production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Responsibilities include but are not limited to:
- Work with Process Development team and Operations organization to successfully transfer process to cGMP facility to manufacture products.
- Support and review site operation, qualification and validation documents to ensure compliance with applicable regulations and Janssen standards.
- Review and approve non-conformances and CAPAs associated with qualification/ validation execution and manufacturing/ facility issues and ensure effectiveness of related actions.
- Review and approve change controls related to manufacturing, laboratory and facility systems.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
- A minimum of 6 years of experience in Quality Assurance related to manufacturing is required.
- Experience working with cell therapy is preferred.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development 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 as well as knowledge of Good Tissue Practices is required. .
- Good written and verbal communication skills are required.
- This position will require occasional travel to Malvern, PA or Spring House, PA as business demands.
- Candidates must be able to accommodate working outside normal business hours (including nights and weekends) on little to no prior notice.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Janssen Pharmaceuticals, Inc (6062)