Cell Therapy QA Floor Specialist II

BioSpace; Raritan (NJ); On-site; USD 78,000 - 103,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Parental leave

Job summary

Legend Biotech, based in the United States, seeks a QA Shop Floor Specialist in Raritan, NJ to oversee the quality of autologous CAR-T product manufacturing within a GMP cleanroom.

The role requires a life sciences or engineering degree with 0–2+ years in biotech/pharma QA, aseptic processing, and SAP/EBR experience. On-site work, weekend flexibility, and strong documentation discipline are expected.

Qualifications

• Bachelor's degree in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent.
• Experience in aseptic manufacturing facilities and QA/compliance.

Responsibilities

• Provide QA oversight of autologous CAR-T production and clinical manufacturing.
• Support cGMP compliance through spot checks and internal audits.
• Review documentation per GDP and SOPs; assist investigations and continuous improvement.

Skills

Quality assurance

cGMP

Aseptic processing

SAP

EBR systems

Teamwork

Attention to detail

Education

Life Sciences degree

Engineering degree

Tools

SAP

EBR systems

Quality systems

Job description

Legend Biotech, based in the United States, seeks a QA Shop Floor Specialist in Raritan, NJ to oversee the quality of autologous CAR-T product manufacturing within a GMP cleanroom.

The role requires a life sciences or engineering degree with 0–2+ years in biotech/pharma QA, aseptic processing, and SAP/EBR experience. On-site work, weekend flexibility, and strong documentation discipline are expected.