BioSpace
QA Shop Floor Specialist – BioSpace
Organization:
Legend Biotech is a global biotechnology company headquartered in Somerset, New Jersey. The company develops advanced cell therapies across multiple platforms, including autologous and allogenic CAR‑T, TCR‑T, and NK cell‑based immunotherapy. Legend Biotech has collaborated with Janssen (Johnson & Johnson) to develop and commercialize ciltacabtagene autolecuel for multiple myeloma.
Location:
Raritan, New Jersey.
Team:
Quality Operations. The QA Shop Floor Specialist is part of this team, responsible for floor quality oversight of autologous CAR‑T production in a controlled cGMP cleanroom environment.
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 guide and determine paths forward for manufacturing quality issues.
Review documentation in accordance with Good Documentation Practices (GDP).
Revise or draft Standard Operating Procedures (SOPs).
Support aseptic process simulations, commercial and clinical manufacturing, and miscellaneous runs to ensure product sterility.
Support batch review and material release in SAP for in‑house reagents.
Conduct floor spot‑checks and audit trail reviews.
Proactively drive compliance to reduce non‑conformances.
Provide quality and compliance input for investigations and continuous improvement.
Approve printed labels and documents prior to floor use (as backup).
Utilize electronic quality systems, batch records, and SAP.
Work collaboratively in a cross‑functional team.
Perform aseptic gowning for Grade B clean rooms and practice aseptic behavior in controlled areas.
Provide ongoing shop floor support for extended periods.
Assist in supporting regulatory inspections and audits.
Adhere to safety, quality, cGMP, and regulatory requirements.
Handle biological materials and hazardous chemicals safely.
Maintain required visual acuity and color perception standards.
Collaborate with quality counterparts across operations, technical support, maintenance, supply chain, and planning.
Qualifications
Bachelor’s degree in Life Sciences or Engineering.
0‑2 + years of biotech/pharmaceutical experience or equivalent industry experience.
Relevant experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Experience supporting clinical manufacture is preferred.
Flexibility to work weekends as needed.
Mobile and able to travel between sites as required.
Strong interpersonal and communication skills.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms.
Able to lift 20 lbs.
Detailed oriented and highly organized, capable of working independently.
Proficient with manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
Skilled in MS Office and other business tools.
Capable of interpreting safety rules, operating instructions, and logbooks.
Strong problem‑solving skills across manufacturing and supply chain processes.
Good written and verbal communication skills.
Capacity to present results and collaborate in teams.
Decision‑making ability with a creative approach while maintaining compliance.
Conflict management and stakeholder communication skills.
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Experience in aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Schedule and Compensation Schedule:
Wednesday – Saturday, 1st Shift.
Base Pay:
$75,972 – $99,713 USD.
Benefits We offer a best‑in‑class benefits package including medical, dental, vision, 401(k) with company match, equity and stock options, paid parental leave, paid time off (vacation, personal, sick), holidays, flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability, legal assistance, supplemental plans, commuter benefits, family planning resources, well‑being initiatives, and recognition programs. Benefits are available exclusively to permanent employees; contract employees are not eligible.
EEO Statement Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We do not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship, age, sex, gender identity, sexual orientation, marital status, military service, veteran status, disability, genetic information, or any protected characteristic under applicable law.
#J-18808-Ljbffr
Legend Biotech is a global biotechnology company headquartered in Somerset, New Jersey. The company develops advanced cell therapies across multiple platforms, including autologous and allogenic CAR‑T, TCR‑T, and NK cell‑based immunotherapy. Legend Biotech has collaborated with Janssen (Johnson & Johnson) to develop and commercialize ciltacabtagene autolecuel for multiple myeloma.
Location:
Raritan, New Jersey.
Team:
Quality Operations. The QA Shop Floor Specialist is part of this team, responsible for floor quality oversight of autologous CAR‑T production in a controlled cGMP cleanroom environment.
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 guide and determine paths forward for manufacturing quality issues.
Review documentation in accordance with Good Documentation Practices (GDP).
Revise or draft Standard Operating Procedures (SOPs).
Support aseptic process simulations, commercial and clinical manufacturing, and miscellaneous runs to ensure product sterility.
Support batch review and material release in SAP for in‑house reagents.
Conduct floor spot‑checks and audit trail reviews.
Proactively drive compliance to reduce non‑conformances.
Provide quality and compliance input for investigations and continuous improvement.
Approve printed labels and documents prior to floor use (as backup).
Utilize electronic quality systems, batch records, and SAP.
Work collaboratively in a cross‑functional team.
Perform aseptic gowning for Grade B clean rooms and practice aseptic behavior in controlled areas.
Provide ongoing shop floor support for extended periods.
Assist in supporting regulatory inspections and audits.
Adhere to safety, quality, cGMP, and regulatory requirements.
Handle biological materials and hazardous chemicals safely.
Maintain required visual acuity and color perception standards.
Collaborate with quality counterparts across operations, technical support, maintenance, supply chain, and planning.
Qualifications
Bachelor’s degree in Life Sciences or Engineering.
0‑2 + years of biotech/pharmaceutical experience or equivalent industry experience.
Relevant experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Experience supporting clinical manufacture is preferred.
Flexibility to work weekends as needed.
Mobile and able to travel between sites as required.
Strong interpersonal and communication skills.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms.
Able to lift 20 lbs.
Detailed oriented and highly organized, capable of working independently.
Proficient with manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
Skilled in MS Office and other business tools.
Capable of interpreting safety rules, operating instructions, and logbooks.
Strong problem‑solving skills across manufacturing and supply chain processes.
Good written and verbal communication skills.
Capacity to present results and collaborate in teams.
Decision‑making ability with a creative approach while maintaining compliance.
Conflict management and stakeholder communication skills.
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Experience in aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Schedule and Compensation Schedule:
Wednesday – Saturday, 1st Shift.
Base Pay:
$75,972 – $99,713 USD.
Benefits We offer a best‑in‑class benefits package including medical, dental, vision, 401(k) with company match, equity and stock options, paid parental leave, paid time off (vacation, personal, sick), holidays, flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability, legal assistance, supplemental plans, commuter benefits, family planning resources, well‑being initiatives, and recognition programs. Benefits are available exclusively to permanent employees; contract employees are not eligible.
EEO Statement Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We do not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship, age, sex, gender identity, sexual orientation, marital status, military service, veteran status, disability, genetic information, or any protected characteristic under applicable law.
#J-18808-Ljbffr