BioSpace
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QA Shop Floor Specialist III
role at
BioSpace .
Legend Biotech is a global biotechnology company dedicated to treating life‑threatening diseases, headquartered in Somerset, New Jersey. The company develops advanced cell therapies across a diverse array of platforms, including autologous and allogenic CAR‑T, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson pharmaceutical company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel), an immunotherapy for multiple myeloma.
Role Overview The QA Shop Floor Specialist is an exempt‑level position responsible for floor quality oversight of the production of autologous CAR‑T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This role ensures compliance with company policies, procedures, and all applicable regulations.
Schedule: Sun‑Wed, 2nd Shift.
Key Responsibilities
Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
Support manufacturing activities for cGMP compliance through spot checks and internal audits.
Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
Review documentation in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs).
Support aseptic process simulations and ensure product sterility is maintained.
Support batch review & material release in SAP for in‑house reagents.
Conduct floor spot‑checks, audit trail reviews.
Drive compliance to reduce non‑conformances.
Assist Investigations team with quality and compliance input.
Approve printed labels and documents prior to use on the manufacturing floor.
Utilize electronic quality systems, batch records, and SAP.
Work cross‑functionally to meet business objectives.
Aseptically gown to support Grade B clean rooms and practice aseptic behavior.
Provide QA shop‑floor support for extended periods.
Support regulatory inspections and audits as needed.
Perform all tasks in adherence to safety policies, quality systems, cGMP, and regulatory requirements.
Other duties as assigned.
Handle biological materials and hazardous chemicals as routine.
Maintain visual acuity of at least 20/30 without corrective lenses.
Meet color perception requirements.
Collaborate with quality counterparts across multiple functions.
Requirements
Bachelor’s degree in Life Sciences or Engineering.
0–2+ years of biotech/pharma experience, or equivalent industry experience.
Relevant experience in an aseptic manufacturing facility, preferably in QA, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Experience with quality support in clinical manufacture preferred.
Flexible to work weekends as needed.
Mobile, able to travel between sites/locations as required.
Strong communication skills; frequent coworker communication required.
Physically able to stand, walk, climb, bend, stoop, and reach with hands and arms.
Ability to lift 20 lbs.
Perform on‑site at manufacturing facility.
Practice good interpersonal skills and positive team orientation.
Continuous learning and professional development.
Proficiency with SAP, electronic batch records, and other manufacturing applications.
Strong MS Office and system skills to improve business effectiveness.
Strong analytical, problem‑solving, and decision‑making abilities.
Ability to interpret and resolve complex issues.
Excellent written and verbal communication skills.
Strong organizational skills and ability to work with minimal supervision.
Compensation Base pay range: $75,972 – $99,713 USD.
Benefits We provide a best‑in‑class benefits package, including medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity options for eligible roles; eight weeks of paid parental leave after three months; paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays); flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning resources; well‑being initiatives; and peer‑to‑peer recognition programs.
EEO Statement Legend Biotech is a proud equal‑opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Our policy ensures equal employment opportunity without discrimination based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by either party. Legend may adjust base salary or other discretionary compensation at any time. Legend Biotech maintains a drug‑free workplace.
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QA Shop Floor Specialist III
role at
BioSpace .
Legend Biotech is a global biotechnology company dedicated to treating life‑threatening diseases, headquartered in Somerset, New Jersey. The company develops advanced cell therapies across a diverse array of platforms, including autologous and allogenic CAR‑T, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson pharmaceutical company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel), an immunotherapy for multiple myeloma.
Role Overview The QA Shop Floor Specialist is an exempt‑level position responsible for floor quality oversight of the production of autologous CAR‑T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This role ensures compliance with company policies, procedures, and all applicable regulations.
Schedule: Sun‑Wed, 2nd Shift.
Key Responsibilities
Provide quality oversight of all aspects of the cell therapy clinical manufacturing process.
Support manufacturing activities for cGMP compliance through spot checks and internal audits.
Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
Review documentation in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs).
Support aseptic process simulations and ensure product sterility is maintained.
Support batch review & material release in SAP for in‑house reagents.
Conduct floor spot‑checks, audit trail reviews.
Drive compliance to reduce non‑conformances.
Assist Investigations team with quality and compliance input.
Approve printed labels and documents prior to use on the manufacturing floor.
Utilize electronic quality systems, batch records, and SAP.
Work cross‑functionally to meet business objectives.
Aseptically gown to support Grade B clean rooms and practice aseptic behavior.
Provide QA shop‑floor support for extended periods.
Support regulatory inspections and audits as needed.
Perform all tasks in adherence to safety policies, quality systems, cGMP, and regulatory requirements.
Other duties as assigned.
Handle biological materials and hazardous chemicals as routine.
Maintain visual acuity of at least 20/30 without corrective lenses.
Meet color perception requirements.
Collaborate with quality counterparts across multiple functions.
Requirements
Bachelor’s degree in Life Sciences or Engineering.
0–2+ years of biotech/pharma experience, or equivalent industry experience.
Relevant experience in an aseptic manufacturing facility, preferably in QA, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Experience with quality support in clinical manufacture preferred.
Flexible to work weekends as needed.
Mobile, able to travel between sites/locations as required.
Strong communication skills; frequent coworker communication required.
Physically able to stand, walk, climb, bend, stoop, and reach with hands and arms.
Ability to lift 20 lbs.
Perform on‑site at manufacturing facility.
Practice good interpersonal skills and positive team orientation.
Continuous learning and professional development.
Proficiency with SAP, electronic batch records, and other manufacturing applications.
Strong MS Office and system skills to improve business effectiveness.
Strong analytical, problem‑solving, and decision‑making abilities.
Ability to interpret and resolve complex issues.
Excellent written and verbal communication skills.
Strong organizational skills and ability to work with minimal supervision.
Compensation Base pay range: $75,972 – $99,713 USD.
Benefits We provide a best‑in‑class benefits package, including medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity options for eligible roles; eight weeks of paid parental leave after three months; paid time off (15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays); flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning resources; well‑being initiatives; and peer‑to‑peer recognition programs.
EEO Statement Legend Biotech is a proud equal‑opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Our policy ensures equal employment opportunity without discrimination based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by either party. Legend may adjust base salary or other discretionary compensation at any time. Legend Biotech maintains a drug‑free workplace.
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