Quality Assurance Associate II (QPIP), CAR-T Manufacturin

Janssen Pharmaceuticals Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II (QPIP), CAR-T Manufacturing.

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 pharmaceutical products? Apply today for this exciting opportunity!

The QA Associate II is a Quality Person in the Plant (QPIP) and is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities:

• Work with Process Development team and Operations organization to successfully transfer process to cGMP facility to manufacture products.
• Support drafting of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor.
• Support aseptic process simulations ensure sterility of the product/process is not compromised.
• Real-time review of all documentation and reporting in support of process unit operations.
• Support material release in SAP for In-house reagents.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Ensure organization of Document Control room and preparation of completed Batch Records for transfer to QA Document Control and Archival
• Monitor warehouse, manufacturing, and manufacturing support activities for cGMP compliance through spot checks/internal audits.
• Support clean room activities.
• Provider QA shop floor support for extended periods of time.
• Support the Shop Floor Order QPIP review and Closure process for executed batches and In House reagents/intermediates
• Other duties will be assigned, as the need arises.