QA Warehouse Specialist III

The role

The QA Warehouse Specialist III supports warehouse activities related to material receipt, handling, and release. This includes incoming and release of patient material and final product at the Raritan, NJ manufacturing site.

What you will do

• Perform incoming inspection and release of materials for CAR-T product manufacturing in a cGMP environment.
• Review, inspect, and disposition incoming materials per inspection plan.
• Review inspection documentation such as C of A or other Material Certifications.
• Conduct routine housekeeping checks of the Warehouse and supporting areas.
• Conduct routine reviews of warehouse documents and logbooks to ensure GDP adherence.
• Ensure materials are in proper location and under appropriate storage conditions.
• Make quality decisions in support of warehouse activities.
• Ensure accurate and timely cycle counts.
• Review and inspect documentation for Final Product Shipments.
• Generate inspection reports and non-conformances for failures.

Required qualifications

• 0-4 years of relevant work experience
• Proficient in the use of quality systems such as SAP
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products
• Knowledge of Good Tissue Practice
• Excellent written and oral communication skills
• Must be able to accommodate unplanned overtime including nights and weekends on little to no prior notice

Nice to have

• Experience working in a cGMP manufacturing facility
• Experience in quality assurance, manufacturing compliance, clinical quality, or cell therapy
• Experience in clinical quality, method development, cell banking, or Research & Development
• Experience working with cell therapy

Benefits

• 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 three (3) months of employment
• Paid time off including vacation time, personal time, sick time, floating holidays, and 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 and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States
• Employment eligibility will be verified through E-Verify

About the company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances cell therapy through innovative technologies.