QA, Shop Floor Specialist II
Legend Biotech
September 02, 2026
On-site
Raritan, NJ
Operations
QA Shop Floor Specialist (Quality) — Raritan, NJ
Role Overview
- Exempt position responsible for floor quality oversight of production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Ensures quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Provide quality oversight of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Guide immediate path forward for manufacturing quality issues.
- Review documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations, manufacturing runs to ensure sterility is not compromised.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-checks/audit trail review.
- Proactively reduce non-conformances; support Investigations for continuous improvement.
- Backup approval of printed labels/documents prior to use on the manufacturing floor.
- Use electronic quality systems, batch records, and SAP.
- Support regulatory inspections/audits; perform work per safety/quality/cGMP requirements.
Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharma experience (aseptic manufacturing preferred), ideally in QA, manufacturing compliance, clinical quality, technical operations, or cell therapy.
- Preferred: quality support in clinical manufacture.
- Flexible for weekends; on-site at manufacturing facility; mobile between sites.
- Strong proficiency: SAP, electronic batch records (EBR), quality systems; MS Office.
- Knowledge of cGMP and FDA/EU guidance for cell-based products; Good Tissue Practices.
- Ability to aseptically gown; lift 20 lbs.
- Strong attention to detail; good written/verbal communication; team collaboration.
Benefits (as stated)
- Medical, dental, vision; 401(k) match (fully vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays) and 11 company holidays. Other voluntary benefits available.
Base pay range: $78,251–$102,705.
Application instructions
- Applicants must be authorized to work in the United States (E-Verify; Form I-9 upon selection).
Role Overview
- Exempt position responsible for floor quality oversight of production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Ensures quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities
- Provide quality oversight of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Guide immediate path forward for manufacturing quality issues.
- Review documentation per Good Documentation Practices (GDP).
- Review, revise, or draft SOPs.
- Support aseptic process simulations, manufacturing runs to ensure sterility is not compromised.
- Support batch review & material release in SAP for in-house reagents.
- Support floor spot-checks/audit trail review.
- Proactively reduce non-conformances; support Investigations for continuous improvement.
- Backup approval of printed labels/documents prior to use on the manufacturing floor.
- Use electronic quality systems, batch records, and SAP.
- Support regulatory inspections/audits; perform work per safety/quality/cGMP requirements.
Requirements
- Bachelor’s degree in Life Sciences or Engineering.
- 0–2+ years biotech/pharma experience (aseptic manufacturing preferred), ideally in QA, manufacturing compliance, clinical quality, technical operations, or cell therapy.
- Preferred: quality support in clinical manufacture.
- Flexible for weekends; on-site at manufacturing facility; mobile between sites.
- Strong proficiency: SAP, electronic batch records (EBR), quality systems; MS Office.
- Knowledge of cGMP and FDA/EU guidance for cell-based products; Good Tissue Practices.
- Ability to aseptically gown; lift 20 lbs.
- Strong attention to detail; good written/verbal communication; team collaboration.
Benefits (as stated)
- Medical, dental, vision; 401(k) match (fully vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays) and 11 company holidays. Other voluntary benefits available.
Base pay range: $78,251–$102,705.
Application instructions
- Applicants must be authorized to work in the United States (E-Verify; Form I-9 upon selection).