Legend Biotech is seeking a QA Warehouse Specialist III as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Warehouse Specialist is an exempt level position with responsibility of supporting Warehouse activities related to material receipt, handling and release as well as incoming and release of patient material/final product at the Raritan, NJ Legend CAR-T manufacturing site.

Key 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 that GDP are being adhered to.
• Ensures that all materials are in the proper location and under the appropriate storage conditions.
• Make appropriate quality decisions in support of warehouse activities.
• Ensure that cycle counts are accurate and performed in a timely manner in accordance to the procedures.
• Review and inspect documentation in support of Final Product Shipments.
• Generates inspection reports and non-conformances for failures as required.
• Scanning, filing and archival of QA related documents.
• Updates supervisor of work status or problems with recommendations for improvement or correction.
• Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
• Other duties will be assigned, as necessary

Requirements

• 0-4 years of relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
• Proficient in the use of quality systems such as SAP.
• Experience working with cell therapy is preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practice is required.
• Excellent written and oral communication skills are required.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

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