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QA Shop Floor Specialist II/III
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BioSpace
1 day ago Be among the first 25 applicants
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a
QA Shop Floor Specialist II/III
as part of the
Quality Operations
team based in
Raritan, New Jersey .
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 position is responsible for quality and maintaining the highest standards in compliance within 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 processes that include aseptic process simulations, commercial and clinical manufacturing, and miscellaneous runs to ensure sterility is maintained.
Support batch review & material release in SAP for in‑house reagents.
Support floor spot‑check and audit trail review.
Strive to reduce non‑conformances by proactively driving compliance.
Support investigations by providing quality and compliance input for continuous improvement and remediation.
Serve as backup for approving printed labels and documents prior to use on the manufacturing floor.
Utilize multiple electronic quality systems, batch records, and SAP.
Work in a team‑based, cross‑functional environment to complete tasks required to meet business objectives.
Must be able to aseptically gown to support grade B clean rooms and practice aseptic behavior in controlled areas.
Provide QA shop floor support for extended periods of time.
Support regulatory inspections and audits as needed.
Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as state and federal regulations.
Other duties will be assigned as needed.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Must have visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or corrected to 20/30 (Snellen) or better with corrective lenses.
Color perception: both eyes 5 slides out of 8.
Collaborate with quality counterparts across Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain, and Planning.
Requirements
Bachelor’s degree in life sciences or engineering.
0–2+ years of biotech/pharmaceutical or equivalent industry experience.
Relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Experience with quality support in clinical manufacture is preferred.
Flexible to work on weekends as needed.
Mobile and able to transport between sites/locations as required.
Required to communicate regularly with coworkers.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms.
Must be able to lift 20 lbs.
Report to work on time.
Duties performed on‑site at manufacturing facility.
Other duties as assigned.
Attend departmental and other scheduled meetings.
Maintain good interpersonal and communication skills.
Demonstrate positive team‑oriented approach.
Promote and work within a team environment.
Learn new skills and procedures as assigned.
Contribute to projects.
Assist in troubleshooting manufacturing issues.
Technical knowledge within functional units.
Understand the process to perform tasks correctly.
Strong proficiency with SAP, electronic batch records, and quality systems.
Utilize Microsoft Office and other systems to improve business effectiveness.
Read and interpret safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret a variety of written, oral, or diagrammatic instructions.
Deal with complexity across the end‑to‑end supply chain process.
Solve practical problems with limited standardization.
Perform basic arithmetic in all units of measure.
Experience with aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Great attention to detail and ability to follow procedures.
Highly organized and able to work in a team with minimal supervision.
Strong written and verbal communication skills.
Summarize and present results; experience with team collaborations.
Interpret problems and determine appropriate resolutions to ensure compliance.
Collaborate well with stakeholders, customers, and peers.
Strong decision‑making and creative thinking while maintaining compliance.
Communicate criticality of issues to management.
Manage conflict and issues arising with internal or external customers.
The anticipated base pay range is $75,972 - $99,713 USD.
Benefits We are committed to creating a workplace where employees can thrive—professionally and personally. To attract and retain top talent, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after just three months of employment; paid time off policy with 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; and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Additional benefits include commuter benefits, family planning and care 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. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment 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 the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
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QA Shop Floor Specialist II/III
role at
BioSpace
1 day ago Be among the first 25 applicants
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a
QA Shop Floor Specialist II/III
as part of the
Quality Operations
team based in
Raritan, New Jersey .
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 position is responsible for quality and maintaining the highest standards in compliance within 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 processes that include aseptic process simulations, commercial and clinical manufacturing, and miscellaneous runs to ensure sterility is maintained.
Support batch review & material release in SAP for in‑house reagents.
Support floor spot‑check and audit trail review.
Strive to reduce non‑conformances by proactively driving compliance.
Support investigations by providing quality and compliance input for continuous improvement and remediation.
Serve as backup for approving printed labels and documents prior to use on the manufacturing floor.
Utilize multiple electronic quality systems, batch records, and SAP.
Work in a team‑based, cross‑functional environment to complete tasks required to meet business objectives.
Must be able to aseptically gown to support grade B clean rooms and practice aseptic behavior in controlled areas.
Provide QA shop floor support for extended periods of time.
Support regulatory inspections and audits as needed.
Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as state and federal regulations.
Other duties will be assigned as needed.
Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
Must have visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or corrected to 20/30 (Snellen) or better with corrective lenses.
Color perception: both eyes 5 slides out of 8.
Collaborate with quality counterparts across Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain, and Planning.
Requirements
Bachelor’s degree in life sciences or engineering.
0–2+ years of biotech/pharmaceutical or equivalent industry experience.
Relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations, or cell therapy.
Experience with quality support in clinical manufacture is preferred.
Flexible to work on weekends as needed.
Mobile and able to transport between sites/locations as required.
Required to communicate regularly with coworkers.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms.
Must be able to lift 20 lbs.
Report to work on time.
Duties performed on‑site at manufacturing facility.
Other duties as assigned.
Attend departmental and other scheduled meetings.
Maintain good interpersonal and communication skills.
Demonstrate positive team‑oriented approach.
Promote and work within a team environment.
Learn new skills and procedures as assigned.
Contribute to projects.
Assist in troubleshooting manufacturing issues.
Technical knowledge within functional units.
Understand the process to perform tasks correctly.
Strong proficiency with SAP, electronic batch records, and quality systems.
Utilize Microsoft Office and other systems to improve business effectiveness.
Read and interpret safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret a variety of written, oral, or diagrammatic instructions.
Deal with complexity across the end‑to‑end supply chain process.
Solve practical problems with limited standardization.
Perform basic arithmetic in all units of measure.
Experience with aseptic processing in ISO 5 clean rooms and biosafety cabinets.
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Great attention to detail and ability to follow procedures.
Highly organized and able to work in a team with minimal supervision.
Strong written and verbal communication skills.
Summarize and present results; experience with team collaborations.
Interpret problems and determine appropriate resolutions to ensure compliance.
Collaborate well with stakeholders, customers, and peers.
Strong decision‑making and creative thinking while maintaining compliance.
Communicate criticality of issues to management.
Manage conflict and issues arising with internal or external customers.
The anticipated base pay range is $75,972 - $99,713 USD.
Benefits We are committed to creating a workplace where employees can thrive—professionally and personally. To attract and retain top talent, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after just three months of employment; paid time off policy with 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; and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Additional benefits include commuter benefits, family planning and care 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. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment 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 the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
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