QA Floor Lead – Cell Therapy GMP Compliance

BioSpace; Raritan (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Legend Biotech in New Jersey seeks a QA Shop Floor Specialist to provide quality oversight of autologous cell therapy manufacturing in a controlled cGMP cleanroom. The role focuses on ensuring compliance with GDP, SOPs, and related quality systems during clinical trial and commercial production.

You will collaborate with site personnel, perform spot checks and audits, review documentation, and support material release in SAP for in-house reagents while upholding the highest standards of product

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 of 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 that are conducted to support manufacturing 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.

Job description

Legend Biotech in New Jersey seeks a QA Shop Floor Specialist to provide quality oversight of autologous cell therapy manufacturing in a controlled cGMP cleanroom. The role focuses on ensuring compliance with GDP, SOPs, and related quality systems during clinical trial and commercial production.

You will collaborate with site personnel, perform spot checks and audits, review documentation, and support material release in SAP for in-house reagents while upholding the highest standards of product