Johnson & Johnson Careers
QA Incoming Inspection Specialist, CAR-T
Raritan, New Jersey
Requisition ID: 7931190220
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Incoming Inspection Specialist, CAR-T.
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
The QA Incoming Inspection Specialist, CAR-T will:
• Be part of the quality team responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment
• Reviews, inspection, and disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to complete receipt process.
• Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.
• Generates inspection reports and non-conformances for failures as required.
• Scanning, filing and archival of QA related documents.
• Supports new product development
• Assist with receiving, shipping or material handling tasks in a backup role, as needed.
• Updates supervisor/manager of work status or problems with recommendations for improvement or correction.
• Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies
• 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 dedicatedly driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.
• A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required.
• A minimum of four (4) years of experience in Quality Assurance related to manufacturing is required.
• A minimum of two (2) years of experience with quality support in clinical manufacture or NPI is preferred
• Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
• Experience working with cell therapy is preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practices is required.
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• This position is located in Raritan, NJ and may require up to 5% of domestic travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
Janssen Pharmaceuticals, Inc (6062)