QA Shop Floor Specialist II
The QA Shop Floor Specialist II at Legend Biotech US is responsible for overseeing the quality aspects of autologous CAR-T cell therapy production within a controlled cGMP cleanroom environment. This role ensures compliance with company policies, procedures, and applicable regulations to maintain the highest quality standards.
Key responsibilities include providing quality oversight of the cell therapy clinical manufacturing process, supervising manufacturing and support activities for cGMP compliance through spot checks and internal audits, and collaborating with site personnel to address manufacturing issues. The specialist will also perform real-time documentation reviews, draft or revise Standard Operating Procedures (SOPs), support aseptic process simulations, and manage material releases in SAP for in-house reagents. Additionally, the role involves supporting investigations for continuous improvement and serving as a backup for approving printed labels and documents used on the manufacturing floor.
Candidates must possess a bachelor's degree in Life Sciences or Engineering and have at least four years of experience in the biotech or pharmaceutical industry, with a minimum of two years in quality roles within an aseptic manufacturing facility. Experience in quality support for clinical manufacturing is preferred. The role requires flexibility to work weekends as needed, mobility to travel between sites, and the ability to stand, walk, bend, and lift up to 20 lbs. Strong proficiency in SAP, electronic batch records, and quality systems, along with excellent written and verbal communication skills, are essential.
Legend Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, and a generous paid time off policy. Additional benefits encompass flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, and various supplemental plans. The company also provides commuter benefits, family planning resources, well-being initiatives, and peer-to-peer recognition programs.
Joining Legend Biotech means becoming part of a global biotechnology company dedicated to treating and potentially curing life-threatening diseases. The company fosters a collaborative and inclusive work environment, offering opportunities for professional growth and development. Employees are encouraged to contribute to innovative cell therapy solutions that make a meaningful impact on patients worldwide.