QA Shop Floor Specialist II

Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for 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, 1st Shift 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 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 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 proactively. Support investigations by providing quality and compliance input for continuous improvement and remediations. Serve as 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 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, cGMP requirements, and state/federal regulations. Other duties will be assigned as needed. 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 with lenses. Color perception 5 slides out of 8. Works collaboratively with quality counterparts across departments. Requirements 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 is preferred. Flexible to work on weekends as needed. Mobile and able to independently transport themselves between sites/locations. Frequent communication with coworkers required. Will regularly stand, walk, climb, bend, stoop, and reach with hands and arms. Ability to lift 20 lbs. Report to work on time. Duties performed on‑site at manufacturing facility. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate a positive team‑oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills and continue to develop professionally. Support and contribute to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units. Understand the process to properly perform assigned tasks. Strong proficiency using relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilize tools within MS Office and other systems to improve business effectiveness. Read and interpret safety rules, operating instructions, and logbooks. Provide feedback for SOPs. Interpret a variety of instructions in written, oral or diagram form. Deal with complexity across drug product, manufacturing process, and end‑to‑end supply chain. Resolve practical problems with limited standardization. Perform basic arithmetic in all units of measure. Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations, FDA/EU guidance on cell‑based products, and Good Tissue Practices. Great attention to detail and ability to follow procedures. Highly organized, capable of working independently with minimal supervision. Good written and verbal communication skills. Summarize and present results; experience with team collaboration required. Interpret problems and determine appropriate resolutions that ensure compliance and minimize risk. Collaborate well with stakeholders, customers and peers. Strong decision‑making ability and creative thinking while maintaining compliance and quality. Communicate critical issues to management. Manage conflict and issues that arise with internal or external customers. Benefits Benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. #J-18808-Ljbffr Legend Biotech USA