QA Warehouse Specialist III

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

8 weeks of paid parental leave after 3

Paid time off: vacation, personal time

Holidays and sick time

Job summary

Legend Biotech USA, Inc. is seeking a QA Warehouse Specialist III to join the Quality team in Raritan, NJ. This exempt role supports warehouse activities, material receipt, handling and release for autologous CAR-T products in a cGMP environment.

You will review inspection docs, ensure GDP compliance, maintain storage conditions, perform cycle counts, and generate inspection reports. Experience in SAP, knowledge of cGMP, and strong written/oral communication are required; overtime may be needed.

Qualifications

• 0–4 years of relevant work experience in a cGMP manufacturing facility.
• Experience in quality assurance, manufacturing compliance, clinical quality, or cell therapy preferred.
• Proficient with quality systems such as SAP.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.
• Excellent written and oral communication skills.
• Willing to accommodate unplanned overtime including nights and weekends.

Responsibilities

• Assist with incoming inspection and release of materials for CAR-T product manufacturing.
• Review inspection documentation (C of A) for inbound materials.
• Maintain GDP adherence and routine housekeeping of the Warehouse.
• Ensure proper storage conditions and location of materials.
• Generate inspection reports and non-conformances as required.
• Support Final Product Shipments documentation.
• Assist with cycle counts and inventory accuracy.
• Escalate issues and propose corrective actions.

Skills

cGMP knowledge

Quality Assurance

Documentation

Communication

Overtime adaptability

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.

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.

Work Authorization & Employment Eligibility

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.