QA Investigation Specialist II, CAR-T

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for QA Investigation Specialist II, CAR-T in Raritan, NJ!

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 Pharmaceutical, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Pharmaceuticals, 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 pharmaceutical products? Apply today for this exciting opportunity!

The CAR-T QA Investigation Specialist II will work with the technical team to ensure comprehensive assessment of nonconformances/deviations.

Key Responsibilities:

• Ensure all non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.
• Provide quality/compliance guidance to resolve quality related issues and/or documentation discrepancies to site personnel.
• Represent the department in interdepartmental meetings in support of process improvement initiatives.
• Escalates issues to management in timely manner and works with management to address and remediate issues.
• Respond swiftly to departmental and interdepartmental needs and requests.
• Support site inspections, inspection readiness activities, data integrity efforts and additional continuous improvement activities.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Other duties will be assigned, as needed.