QA, Shop Floor Specialist I​/II

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 role is responsible for quality and maintaining high standards in compliance with 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 and internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward 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 process simulations, Commercial & clinical manufacturing, and miscellaneous runs to ensure sterility of the product/process is not compromised.
• 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 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 are not limited to tasks mentioned above.
• Support regulatory inspections and audits as needed.
• Perform tasks in adherence with safety policies, quality systems, and cGMP requirements, and relevant state and federal regulations.
• Other duties as assigned and required.
• Roles involve exposure to and handling of biological materials and hazardous chemicals.
• Maintain appropriate visual and physical capabilities to perform duties and ensure product quality.
• Collaborate with 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.
• 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 is preferred.
• Willingness to work on weekends, as needed.
• Must be mobile and able to independently travel between sites/locations as required.
• Strong communication skills and ability to work in a collaborative team environment.
• Physical ability to stand, walk, climb, bend, stoop, and reach with hands and arms; ability to lift up to 20 lbs.
• On-site presence at the manufacturing facility is required.
• Read and interpret documents such as safety rules, operating instructions, and logbooks.
• Proficiency with SAP, electronic batch records (E ), and quality systems; MS Office skills.
• Ability to summarize and present results and work effectively with cross-functional teams.
• Strong problem-solving, decision-making, and communication skills; ability to resolve issues while maintaining compliance and quality.
• Ability to collaborate with internal and external stakeholders and maintain a positive, team-oriented attitude.

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.