QA, Shop Floor Specialist II

The role

The QA Shop Floor Specialist provides quality oversight for the production of autologous CAR-T products in a cGMP cleanroom environment. This role involves reviewing documentation, supporting manufacturing compliance, and conducting floor spot checks.

What you will do

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review of all documentation, in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs).
• Support processes that include aseptic process simulations, Commercial & clinical manufacturing, and miscellaneous runs.
• Support batch review & material release in SAP for In-house reagents.
• Support Floor Spot-check, audit trail review.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.

Required qualifications

• Bachelor’s degree required in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
• Relevant working experience in an aseptic manufacturing facility.
• Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
• Must be able to independently transport themselves between various sites/locations.
• Regularly required to stand, walk, climb, bend, stoop, and reach with hands and arms.
• Ability to lift 20 lbs.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or 20/30 or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.
• Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Good written and verbal communication skills.

Nice to have

• Experience with quality support in clinical manufacture is preferred.

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, personal, sick, 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, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances the next generation of cell therapy.