QA, Shop Floor Specialist II

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist (2nd Shift) as part of the Quality team based in Raritan, NJ. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses. Color Perception both eyes 5 slides out of 8. Requirements Bachelor’s degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. <span style="font-family: arial, helvetica, sans-serif; font-size: