QA Lab Oversight Associate

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Lab Oversight Associate!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create 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 collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed 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!

In this role, you will be providing quality oversight of Quality Control laboratories responsible for analytical testing of clinical and commercial CAR-T cell therapy products. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

Main responsibilities will include, but are not limited to:

• Partner with Quality Control teams to support analytical method transfers and routine release and stability testing activities of CAR-T cell therapy products.
• Perform regularly scheduled oversight of the QC laboratories.
• Review paper and electronic laboratory documentation for completeness and accuracy.
• Review and approve certificates of analysis where required.
• Author and revise quality departmental documents.
• Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
• Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
• Provide quality oversight for sample management activities.
• Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
• Support site inspections and inspection readiness activities. Ensure the laboratories are audit ready. Support data integrity efforts.
• Other duties may be assigned as necessary.