Quality Assurance Specialist III – Lentiviral Vector

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Specialist III – Lentiviral Vector! 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? The QA Specialist III is responsible for providing quality oversight over a wide range of activities and projects in the Lentivirus Vector (LVV) facility to support clinical and commercial efforts. This role offers an opportunity to get in at the beginning and help craft the quality and compliance systems of our LVV team. Key Responsibilities: QA oversight of LVV manufacturing process to ensure cGMP compliance. Review Master Batch Records to confirm data is accurate, legible, and consistent with established GDP requirements. Perform manufacturing documentation compilation and quality issue assessment for the release of Lentiviral Vector product. Perform inspection and release of raw materials needed for LVV production, as required. Support review, revision, or drafting Standard Operating Procedures (SOPs) for Quality department in relation to the LVV process. Provide quality and compliance input for continuous improvement and corrective actions of GxP practices within the lentivirus vector manufacturing facility. Collaborate in a team based, cross-functional environment to complete tasks required by shift schedule. Maintain quality practices and perform tasks in accordance to state and federal regulatory requirements and cGMP requirements. Collaborate with functional departments to resolve issues related to LVV production, batch review, and release. Clear communication with other QA LVV team members, to ensure consistent performance, and identification of deviations. Ensure readiness of records for regulatory inspections. Review, compile, and organize data for trending. Qualifications Education: Minimum of a Bachelor’s or equivalent University Degree in Science, Information Science, or equivalent technical field is required Experience and Skills: Required: Minimum 4 years of relevant work experience Experience in Quality Assurance and/or Quality Systems Compliance Knowledge of cGMP and FDA regulations Good written and verbal communication skills Preferred: Experience working with large molecules or Lentivirus vector production Knowledge of Good Tissue Practice or experience with cell-based manufacturing Experience working in an aseptic manufacturing facility Knowledge of EU guidance Other: Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-New Jersey-Raritan-1000 US HIghway 202 Organization Janssen Pharmaceuticals, Inc. (6062) Job Function Quality Requisition ID 2206058660W