Quality Assurance Associate II

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II!

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 for daily activities related to the production of lentiviral vector in a controlled cGMP clean room environment. 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 the GMP Operations teams to support technology transfer activities and manufacturing processes into the cGMP facility.
• Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment.
• Perform review and approval of completed batch records and production documentation in support of batch release activities including preparation of product release documentation.
• Review and approve controlled documents including standard operating procedures, master batch records, 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 of the maintenance program, including facility change requests, calibrations, corrective and preventative maintenance and pest control.
• Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
• 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.
• Other duties may be assigned as necessary.