Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Manufacturing Investigation Associate, 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 Manufacturing Investigation Associate, CAR-T Will Interview personnel on the manufacturing floor and provide quality insight to complete reports in Trackwise Review/complete routine CAR-T manufacturing nonconformance/deviation investigations Proactively work with stakeholders to ensure the timely completion of corrective and preventive actions Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders Implement effective corrective and preventative actions to avoid recurrence of deviations Work closely with management to propose/execute improvements through the change management system Represent the department in cross functional teams in support of process improvement initiatives Ability to respond with a high degree of urgency to departmental and cross functional needs and requests. Reporting/Monitoring metrics on non-conformance investigations, corrective and preventive actions (CAPA), Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary.Qualifications 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. Experience in clinical quality, gene and cell therapies, or Research & Development is preferred. Experience working with cell therapy is preferred. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred. 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. Good written and verbal communication skills are required. Candidates must be able to accommodate shift schedule, including routine weekend and evening, if needed. Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice, if needed. This position is located in Raritan, NJ.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 LocationUnited States-New Jersey-Raritan-OrganizationJanssen Pharmaceuticals, Inc (6062)Job FunctionQuality AssuranceRequisition ID882####### by Jobble Associated topics: bio, biochemistry, biology, biomaterials, biomechanics, biomedical engineer, enzyme, medical, neurodegenerative, pharmaceutical
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