QA, Shop Floor Specialist I​/II

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Assurance team based in Raritan, NJ
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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 of compliance within company policies, procedures, and all applicable regulations.

• 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 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 the investigations team by providing quality and compliance input for continuous improvement and remediation.
• 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.
• 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.
• Visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or corrected to 20/30 (Snellen) or better with corrective lenses.
• Color perception both eyes 5 slides out of 8.
• Works in a collaborative team setting with quality counterparts that include manufacturing operations, operations technical support, maintenance, supply chain and planning.

• 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.
• While performing the duties of this job, the employee is regularly required to stand; walk; climb; bend and stoop; and reach with hands and arms.
• Ability to lift 20 lbs.
• Report to work on time.
• Duties…