QA Laboratory Compliance Specialist III

Responsibilities

• Provide quality and compliance oversight over all functions of the Quality Control Laboratories
• Train and coach Level I/II QALC staff on day-to-day activities
• Perform ad-hoc walk-throughs of QC labs to ensure GMP compliance
• Conduct formbook reviews, SOP reviews, and quarterly trend reports
• Collaborate with cross-functional teams to develop strategic approaches to complex investigations
• Monitor the lifecycle of investigations and ensure timely approval and closure
• Ensure Corrections and CAPA actions are implemented for investigations
• Support regulatory inspections and audits by ensuring QC areas are audit-ready

Requirements

• Bachelor’s Degree in Science or equivalent technical discipline
• Minimum of 2 years relevant work experience
• Minimum of 1 year experience in Quality Assurance
• Strong knowledge of Nonconformance and CAPA management processes
• Knowledge of cGMP/cGLP regulations and FDA/EU guidance
• Experience reviewing GMP documentation including SOPs, Investigations, and Change Controls
• Proficiency in Microsoft Office applications
• Ability to work on-site all days of the week

Preferred Qualifications

• Experience in an aseptic manufacturing facility
• Experience in cell therapy or CAR-T manufacturing
• Knowledge of cell processing

About the Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across diverse technology platforms, including autologous and allogenic chimeric antigen receptor T-cell (CAR-T) immunotherapy.