QA Warehouse Specialist III — Cell Therapy GMP (Raritan)

Legend Biotech USA, Inc.; Raritan (NJ); On-site; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

8 weeks of paid parental leave after 3

Paid time off: vacation, personal time

Holidays and sick time

Job summary

Legend Biotech USA, Inc. is seeking a QA Warehouse Specialist III to join the Quality team in Raritan, NJ. This exempt role supports warehouse activities, material receipt, handling and release for autologous CAR-T products in a cGMP environment.

You will review inspection docs, ensure GDP compliance, maintain storage conditions, perform cycle counts, and generate inspection reports. Experience in SAP, knowledge of cGMP, and strong written/oral communication are required; overtime may be needed.

Qualifications

• 0–4 years of relevant work experience in a cGMP manufacturing facility.
• Experience in quality assurance, manufacturing compliance, clinical quality, or cell therapy preferred.
• Proficient with quality systems such as SAP.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.
• Excellent written and oral communication skills.
• Willing to accommodate unplanned overtime including nights and weekends.

Responsibilities

• Assist with incoming inspection and release of materials for CAR-T product manufacturing.
• Review inspection documentation (C of A) for inbound materials.
• Maintain GDP adherence and routine housekeeping of the Warehouse.
• Ensure proper storage conditions and location of materials.
• Generate inspection reports and non-conformances as required.
• Support Final Product Shipments documentation.
• Assist with cycle counts and inventory accuracy.
• Escalate issues and propose corrective actions.

Skills

cGMP knowledge

Quality Assurance

Documentation

Communication

Overtime adaptability

Tools

SAP

Job description

Legend Biotech USA, Inc. is seeking a QA Warehouse Specialist III to join the Quality team in Raritan, NJ. This exempt role supports warehouse activities, material receipt, handling and release for autologous CAR-T products in a cGMP environment.

You will review inspection docs, ensure GDP compliance, maintain storage conditions, perform cycle counts, and generate inspection reports. Experience in SAP, knowledge of cGMP, and strong written/oral communication are required; overtime may be needed.