Cell Therapy QA Floor Specialist I/II

Initial Therapeutics, Inc.; Raritan (NJ); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company 1:

Paid time off and holidays

Job summary

Legend Biotech is seeking a QA Shop Floor Specialist to provide quality oversight of autologous CAR‑T production in a cGMP cleanroom. The role ensures adherence to GDP, SOPs, and safety while supporting continuous improvement across manufacturing operations.

The position requires a Bachelor's in Life Sciences or Engineering, 0–2 years in biotech/pharma, and willingness to work on-site at the Raritan, NJ facility with cross‑functional collaboration.

Qualifications

• Bachelor's degree in Life Sciences or Engineering.
• 0–2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
• Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
• Experience with quality support in clinical manufacture is preferred.

Responsibilities

• Provide QA 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 all documentation, in accordance with GDP.

Skills

Attention to detail

Communication skills

Team collaboration

Organization

Aseptic technique

Problem solving

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or Engineering

Tools

SAP

Electronic Batch Records (EBR)

Quality systems

MS Office

Job description

Legend Biotech is seeking a QA Shop Floor Specialist to provide quality oversight of autologous CAR‑T production in a cGMP cleanroom. The role ensures adherence to GDP, SOPs, and safety while supporting continuous improvement across manufacturing operations.

The position requires a Bachelor's in Life Sciences or Engineering, 0–2 years in biotech/pharma, and willingness to work on-site at the Raritan, NJ facility with cross‑functional collaboration.