QC Investigation Support Specialist (1 of 5)
Publication date:
25 October 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Johnson
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Investigation Support Specialist (CAR-T) in Raritan, NJ!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!
The Specialist will be responsible for leading deviations and corrective actions in support of the Quality Control (QC) testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Key Responsibilities:
- Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
- Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.
- Proactively work with team members to implement effective corrective and preventive actions (CAPAs) and to ensure the timely completion of CAPAs within the laboratories.
- Provide recommendations for the improvement of processes by working cross-functionally with multiple collaborators.
- Work closely with management to propose/execute improvements through the change management system.
- Ability to respond with a high degree of urgency to departmental and cross-functional needs and requests.
- Report/monitor metrics on non-conformance investigations and CAPAs.
- Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
Contact
Synthes GmbH