Senior QC Investigation Support Specialist (CAR-T)

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior QC Investigation Support Specialist (CAR-T)!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic teamwork to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is crafted to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

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 Senior 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.