QA Shop Floor Specialist II

Overview

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 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.

The QA Shop Floor Specialist III is part of the Quality Operations team based in Raritan, New Jersey
. This exempt position is responsible for floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment. The role requires upholding quality standards in compliance with company policies, procedures, and all applicable regulations.

Schedule: Wed–Sat, 1st Shift

• 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 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 and clinical manufacturing, and miscellaneous runs to ensure sterility of the product/process.
• Support batch review and material release in SAP for in-house reagents.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Support Investigations team with 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 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.
• Support regulatory inspections and audits as needed.
• Adhere to safety policies, quality systems, and cGMP requirements, and comply with state and federal regulations.
• Perform other duties as assigned and handle biological materials and hazardous chemicals in accordance with procedures.

• Bachelors degree required in Life Sciences or Engineering.
• 0–2+ years Biotech/Pharma experience or equivalent industry experience.
• 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 manufacturing preferred.
• Flexible to work on weekends, as needed.
• Must be mobile and able to travel between sites/locations as required.
• Strong analytical, written, and verbal communication skills; ability to work independently and in a team.
• Ability to stand, walk, climb, bend, stoop, and reach; ability to lift up to 20 lbs.
• On-site manufacturing facility duties; ability to perform and participate in aseptic processing in ISO 5 clean rooms.
• Proficiency with SAP, electronic batch records (E ), and related quality systems.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products;
  Good Tissue Practices knowledge preferred.

The base pay range is $75,972 – $99,713 USD and may vary based on experience, skills, qualifications, and location. Legend Biotech offers performance-based bonus and/or equity where eligible.

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