QA Warehouse Specialist III

legendcareers; Raritan (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Legend Biotech, based in New Jersey, is seeking a QA Warehouse Specialist III to join the Quality team in Raritan. You will be responsible for incoming inspection, release of materials, and maintaining GMP and GDP standards in a cGMP environment.

The role requires 0–4 years of related experience, familiarity with SAP, and strong documentation and communication skills. It offers competitive pay, benefits, and opportunities to contribute to autologous CAR-T product manufacturing.

Qualifications

• Experience in a cGMP manufacturing facility preferred.
• Experience in clinical quality or cell therapy preferred.
• Excellent written and oral communication skills.
• Proficient with SAP quality systems.
• FDA/EU guidance knowledge related to manufacturing of cell-based products.

Responsibilities

• Perform incoming inspection and release of manufacturing materials.
• Review certificates of analysis and material certifications for inbound materials.
• Maintain housekeeping and GDP adherence in the warehouse.
• Ensure proper storage conditions and accurate inventory cycle counts.
• Generate inspection reports and non-conformances as needed.
• Archive QA documents and communicate issues to supervisor.

Skills

cGMP knowledge

Communication skills

Tools

SAP

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

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

Role Overview

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.

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-