QA Shop Floor Specialist II

Responsibilities

• 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
• Review all documentation in accordance with Good Documentation Practices (GDP)
• Review, revise, or draft Standard Operating Procedures (SOPs)
• Support batch review and material release in SAP for in-house reagents
• Support investigations team by providing quality and compliance input for continuous improvement
• Perform aseptic gowning to support Grade B cleanrooms
• Support regulatory inspections and audits as needed

Requirements

• Bachelor's degree in Life Sciences or Engineering
• 0-2+ years of Biotech or Pharmaceutical experience
• Relevant working experience in an aseptic manufacturing facility
• Proficiency with SAP, electronic batch records (EBR), and quality systems
• Ability to work 2nd shift (Wed-Sat) and weekends as needed
• Ability to lift 20 lbs and perform physical tasks like standing, walking, and climbing
• Visual acuity of 20/30 or better

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, they develop advanced cell therapies including autologous and allogenic CAR-T, TCR-T, and NK cell-based immunotherapy.