QA Warehouse Specialist III - Cell Therapy QC & Compliance

BioSpace

Raritan (NJ)

On-site

USD 96,000 - 126,000

Full time

3 days ago
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Benefits offered by this job

Medical, dental, and vision insurance
401(k) with company match
Paid parental leave
Vacation, personal, sick time and 11+ 

Job summary

Legend Biotech, a leading CAR-T cell therapy company, seeks a QA Warehouse Specialist III for the Raritan, NJ site. In this exempt role, you will support material receipt, handling, and release within a controlled cGMP environment and collaborate with the quality team.

Responsibilities include inspecting inbound materials, reviewing certificates, maintaining records, and ensuring proper storage. Requirements: 0–4 years in a cGMP setting; SAP experience preferred.

Qualifications

  • 0-4 years of relevant work experience is required.
  • Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
  • Proficient in the use of quality systems such as SAP.

Responsibilities

  • Be part of the quality team responsible for incoming inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP environment.
  • Reviews, inspects, and disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to complete receipt process.
  • Reviews inspection documentation (C of A or other Material Certifications) for inbound materials.
  • Conducts routine housekeeping checks of the Warehouse and supporting areas.
  • Conducts routine reviews of warehouse documents and logbooks to ensure GDP adherence.
  • Ensures materials are in the proper location and under appropriate storage conditions.
  • Make appropriate quality decisions in support of warehouse activities.
  • Review and inspect documentation in support of Final Product Shipments.

Tools

SAP

Job description

Legend Biotech, a leading CAR-T cell therapy company, seeks a QA Warehouse Specialist III for the Raritan, NJ site. In this exempt role, you will support material receipt, handling, and release within a controlled cGMP environment and collaborate with the quality team.

Responsibilities include inspecting inbound materials, reviewing certificates, maintaining records, and ensuring proper storage. Requirements: 0–4 years in a cGMP setting; SAP experience preferred.

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