QA Shop Floor Specialist II — GMP Cell Therapy Quality

Legend Biotech; Raritan (NJ); Sur place; USD 78 251 - 102 705; Plein temps

Avantages offerts par ce poste

Medical, dental and vision insurance

401(k) with company match

Paid parental leave and generous PTO

Résumé du poste

Legend Biotech is seeking a QA Shop Floor Specialist in Raritan, NJ to provide on-site quality oversight of autologous CAR‑T production in a cGMP cleanroom. You will ensure GDP-compliant documentation, support aseptic manufacturing, and drive quality improvements across the manufacturing and quality systems.

The role requires 0–2+ years in biotech/pharma, a Life Sciences or Engineering bachelor’s degree, and the ability to work weekends if needed.

Qualifications

• Bachelor’s degree required in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
• Experience in aseptic manufacturing facility and quality assurance roles preferred.

Responsabilités

• 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 guide quality issue resolutions.
• Review documentation per Good Documentation Practices (GDP).
• Review, revise, or draft SOPs.
• Support aseptic processing simulations and manufacturing runs to ensure sterility.
• Assist in batch review & material release in SAP for in-house reagents.
• Work toward reducing non-conformances and enable continuous improvement.
• Support Investigations with quality input and remediation plans.
• Back up approval of printed labels and documents on the floor.

Connaissances

Quality oversight

GDP compliance

SOP drafting/review

cGMP knowledge

SAP

Electronic Batch Records (EBR)

Quality systems

Strong attention to detail

Formation

Bachelor’s degree in Life Sciences or Engineering

Outils

SAP

Electronic Batch Records (EBR)

Quality systems

Description du poste

Legend Biotech is seeking a QA Shop Floor Specialist in Raritan, NJ to provide on-site quality oversight of autologous CAR‑T production in a cGMP cleanroom. You will ensure GDP-compliant documentation, support aseptic manufacturing, and drive quality improvements across the manufacturing and quality systems.

The role requires 0–2+ years in biotech/pharma, a Life Sciences or Engineering bachelor’s degree, and the ability to work weekends if needed.