CAR-T QA Batch Release Specialist Locations:Raritan, New Jersey Functions:Quality Assurance -Job Description -Requisition ID: 856####### Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Batch Release Specialist, CAR-T, located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The QA Batch Release Specialist, CAR-T will: Join the quality team responsible for all paper/electronic batch record reviews related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Review documentation for all manufacturing activity execution in accordance with good documentation practices. Independently execute paper/electronic batch record review associated with commercial, development, and engineering production. Perform duties within a team according to an assigned, production shift schedule, under limited supervision and according to standard operating and manufacturing procedures. Contribute to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines. Collaborate within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory. Implement appropriate corrective and preventive actions by investigating non-conformances in a timely manner. 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.
Qualifications Qualifications: A minimum of a Bachelors Degree in Engineering, Science or equivalent technical discipline is required. A minimum of six (6) years of experience in Quality Assurance related to manufacturing is required. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices is required. Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred. Additional minimum requirements include two (2) years of experience with quality support in clinical manufacturing or New Product Introduction (NPI).
Key Capabilities, Knowledge, and Skills: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets. Proven history of producing and getting results in sales or in a functional group such as commercial operations. Exhibit high skills in the following: attention to detail, following procedures, organizational skills, written and verbal communications. Excel at working in a team environment with a positive attitude and limited supervision. You will be required to maintain written records of work in the form of notebooks, technical reports and protocols. Flexible to work on weekends, as needed. 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.
Primary Location United States-New Jersey-Raritan- Organization Janssen Pharmaceuticals, Inc (6062) Job Function Quality Assurance Requisition ID 856#######