QA Warehouse Specialist III

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan with company-mq

Parental leave

Paid time off

Sick time

Holiday entitlement

Life insurance

Disability coverage

Well-being initiatives

Job summary

Legend Biotech is seeking a QA Warehouse Specialist III for the Quality team based in Raritan, NJ. This exempt role supports material receipt, handling, and release for CAR‑T products at the Raritan site, ensuring GMP and GDP compliance.

Responsibilities include review of inbound material documentation, disposition per inspection plans, and timely non-conformance reporting. Candidate should have cGMP experience and strong communication skills.

Qualifications

• Experience in a cGMP manufacturing facility, preferably in quality assurance or manufacturing compliance.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.
• Excellent written and verbal communication skills.
• Ability to accommodate unplanned overtime including nights and weekends.

Responsibilities

• Support warehouse activities related to material receipt, handling and release for autologous CAR-T products.
• Review and disposition of incoming materials and related documentation per inspection plan.
• Ensure proper storage conditions and GDP adherence in the warehouse.
• Generate inspection reports and non-conformances as required.
• Maintain accurate cycle counts and document control for QA records.

Skills

Quality Assurance

cGMP

SAP

Cell therapy

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

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.

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
• 401(k) retirement plan with a company match that vests fully on day one
• eight (8) weeks of paid parental leave after just three (3) months of employment
• paid time off policy that includes vacation time
• personal time
• sick time
• floating holidays
• eleven (11) company holidays
• flexible spending and health savings accounts
• life and AD&D insurance
• short- and long-term disability coverage
• legal assistance
• supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• voluntary commuter benefits
• family planning and care resources
• well‑being initiatives
• 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.

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.