QA, Shop Floor Specialist I/II
Legend Biotech
August 07, 2026
On-site
Raritan, NJ
Operations
Role Overview:
The QA Shop Floor Specialist is an exempt level position responsible for floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Maintain quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities:
- Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to determine immediate path forward for manufacturing quality issues.
- Review documentation per Good Documentation Practices (GDP).
- Review/revise/draft SOPs.
- Support aseptic process simulations, manufacturing runs, and sterility assurance.
- Support batch review & material release in SAP for in-house reagents; floor spot-check and audit trail review.
- Reduce non-conformances through proactive compliance.
- Provide quality/compliance input for investigations, continuous improvement, and remediations.
- Backup for approving printed labels and documents prior to use.
- Utilize electronic quality systems, batch records, and SAP; support regulatory inspections/audits as needed.
Requirements:
- Bachelor’s degree in Life Sciences or Engineering; 0–2+ years biotech/pharma experience.
- Relevant experience in an aseptic manufacturing facility (preferably QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Knowledge of cGMP regulations; FDA/EU guidance; Good Tissue Practices.
- Strong proficiency with SAP, electronic batch records (EBR), and quality systems; MS Office.
- Flexible for weekends as needed; on-site work in manufacturing facility.
- Ability to aseptically gown (Grade B clean rooms), lift 20 lbs, and work in a standing/walking/bending environment.
Benefits (as stated): Medical, dental, vision; 401(k) with match; 8 weeks paid parental leave after 3 months; paid time off; base pay range $68,045–$95,540; performance bonus/equity for eligible roles.
Application Instructions:
Applicants must be authorized to work in the United States; employment eligibility verified via E-Verify (Form I-9).
The QA Shop Floor Specialist is an exempt level position responsible for floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Maintain quality and compliance with company policies, procedures, and applicable regulations.
Key Responsibilities:
- Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Support cGMP compliance via spot checks/internal audits.
- Collaborate with site personnel to determine immediate path forward for manufacturing quality issues.
- Review documentation per Good Documentation Practices (GDP).
- Review/revise/draft SOPs.
- Support aseptic process simulations, manufacturing runs, and sterility assurance.
- Support batch review & material release in SAP for in-house reagents; floor spot-check and audit trail review.
- Reduce non-conformances through proactive compliance.
- Provide quality/compliance input for investigations, continuous improvement, and remediations.
- Backup for approving printed labels and documents prior to use.
- Utilize electronic quality systems, batch records, and SAP; support regulatory inspections/audits as needed.
Requirements:
- Bachelor’s degree in Life Sciences or Engineering; 0–2+ years biotech/pharma experience.
- Relevant experience in an aseptic manufacturing facility (preferably QA, manufacturing compliance, clinical quality, technical operations, or cell therapy).
- Knowledge of cGMP regulations; FDA/EU guidance; Good Tissue Practices.
- Strong proficiency with SAP, electronic batch records (EBR), and quality systems; MS Office.
- Flexible for weekends as needed; on-site work in manufacturing facility.
- Ability to aseptically gown (Grade B clean rooms), lift 20 lbs, and work in a standing/walking/bending environment.
Benefits (as stated): Medical, dental, vision; 401(k) with match; 8 weeks paid parental leave after 3 months; paid time off; base pay range $68,045–$95,540; performance bonus/equity for eligible roles.
Application Instructions:
Applicants must be authorized to work in the United States; employment eligibility verified via E-Verify (Form I-9).