QA Shop Floor Specialist II

Legend Biotech

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 entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. 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.

Schedule:

Wed‑Sat, 2nd Shift.

The QA Shop Floor Specialist will ensure quality compliance throughout the cell therapy manufacturing process, support audits and inspections, and work cross‑functionally with manufacturing and other operations teams.

• Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks and internal audits.
• Collaborate with site personnel to provide guidance and determine immediate actions for manufacturing quality issues.
• Review documentation in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs).
• Support processes that include aseptic simulations, commercial & clinical manufacturing, and miscellaneous runs to ensure product sterility.
• Support batch review and material release in SAP for in‑house reagents.
• Support floor spot checks and audit trail reviews.
• Proactively drive compliance to reduce non‑conformances.
• Provide quality and compliance input for investigations, continuous improvement, and remediation.
• Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
• Utilize electronic quality systems, batch records, and SAP.
• Work in a cross‑functional team environment to meet business objectives.
• Aseptically gown to support Grade B Clean rooms and 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 state and federal regulatory requirements.
• Other duties will be assigned as needed.
• Job duties 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 corrected to 20/30 (Snellen) or better with corrective lenses.
• Color perception both eyes 5 slides out of 8.
• Work collaboratively with quality counterparts across Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain, and Planning.

• Bachelor’s degree in Life Sciences or Engineering.
• 0–2+ years of biotech/pharmaceutical experience or equivalent industry experience.
• Relevant 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 preferred.
• Flexibility to work on weekends as needed.
• Mobile and able to transport…