QA Warehouse Specialist III

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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Pay and benefits

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.

Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.

We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$96,267—$126,351 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.