BioSpace
Job Title
QA Shop Floor Specialist II/III at BioSpace (Legend Biotech)
Location: Raritan, New Jersey
Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the 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 maintains the highest standards of compliance within company policies, procedures, and all applicable regulations.
Key Responsibilities
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 documentation in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs).
Support processes that ensure sterility of the product/process is not compromised, including aseptic process simulations, commercial & clinical manufacturing, and miscellaneous runs.
Support batch review & material release in SAP for in‑house reagents.
Support floor spot‑check and 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 remediation.
Serve as a 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.
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 according to state and federal regulatory requirements.
Other duties will be assigned as needed.
Job duties involve exposure to and handling of biological materials and hazardous chemicals.
Maintain visual acuity of at least 20/30 (Snellen) unaided or with corrective lenses.
Maintain color perception of both eyes as required.
Work collaboratively 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 experience 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 various sites/locations.
Strong communication skills with coworkers.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms on a regular basis.
Ability to lift 20 lbs.
Report to work on time.
Duties performed on‑site at manufacturing facility.
Practice good interpersonal and communication skills.
Demonstrate a positive team‑oriented approach in daily procedures.
Promote and work within a team environment.
Learn new skills, procedures and processes as assigned by management.
Support and contribute to projects.
Assist in troubleshooting issues related to manufacturing.
Technical knowledge within functional units.
Demonstrate understanding of the process to properly perform assigned tasks.
Strong proficiency utilizing SAP, electronic batch records (EBR), and quality systems.
Utilize tools within MS Office and other systems to improve business effectiveness.
Read and interpret documents such as safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret a variety of instructions furnished in written, oral, or diagram.
Deal with complexity across the drug product, manufacturing process, and supply chain.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Execute calculations in units of measure using whole numbers, common fractions, and decimals.
Perform aseptic processing in ISO 5 clean room and biosafety cabinets.
Have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, as well as Good Tissue Practices.
Display great attention to detail and follow procedures.
Be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Summarize and present results; experience with team‑based collaborations is a must.
Interpret problems and determine appropriate resolutions that ensure compliance and minimize risk.
Collaborate well with stakeholders, customers, and peers.
Exhibit strong decision‑making ability and think creatively while maintaining compliance and quality.
Discern the criticality of issues and communicate to management regarding complex issues.
Manage conflict and issues that arise with internal or external customers.
Salary Range USD $75,972 – $99,713
Benefits We offer a comprehensive benefits package that includes medical, dental, and vision insurance, a 401(k) retirement plan with company match (vested fully on day one), equity and stock options (for eligible roles), eight weeks of paid parental leave after three months of employment, and a paid time off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include 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, 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. Employment is at‑will and may be terminated at any time with or without cause or notice. Legend Biotech maintains a drug‑free workplace.
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Location: Raritan, New Jersey
Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the 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 maintains the highest standards of compliance within company policies, procedures, and all applicable regulations.
Key Responsibilities
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 documentation in accordance with Good Documentation Practices (GDP).
Review, revise, or draft Standard Operating Procedures (SOPs).
Support processes that ensure sterility of the product/process is not compromised, including aseptic process simulations, commercial & clinical manufacturing, and miscellaneous runs.
Support batch review & material release in SAP for in‑house reagents.
Support floor spot‑check and 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 remediation.
Serve as a 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.
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 according to state and federal regulatory requirements.
Other duties will be assigned as needed.
Job duties involve exposure to and handling of biological materials and hazardous chemicals.
Maintain visual acuity of at least 20/30 (Snellen) unaided or with corrective lenses.
Maintain color perception of both eyes as required.
Work collaboratively 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 experience 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 various sites/locations.
Strong communication skills with coworkers.
Ability to stand, walk, climb, bend, stoop, and reach with hands and arms on a regular basis.
Ability to lift 20 lbs.
Report to work on time.
Duties performed on‑site at manufacturing facility.
Practice good interpersonal and communication skills.
Demonstrate a positive team‑oriented approach in daily procedures.
Promote and work within a team environment.
Learn new skills, procedures and processes as assigned by management.
Support and contribute to projects.
Assist in troubleshooting issues related to manufacturing.
Technical knowledge within functional units.
Demonstrate understanding of the process to properly perform assigned tasks.
Strong proficiency utilizing SAP, electronic batch records (EBR), and quality systems.
Utilize tools within MS Office and other systems to improve business effectiveness.
Read and interpret documents such as safety rules, operating instructions, and logbooks.
Review and provide feedback for SOPs.
Interpret a variety of instructions furnished in written, oral, or diagram.
Deal with complexity across the drug product, manufacturing process, and supply chain.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Execute calculations in units of measure using whole numbers, common fractions, and decimals.
Perform aseptic processing in ISO 5 clean room and biosafety cabinets.
Have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, as well as Good Tissue Practices.
Display great attention to detail and follow procedures.
Be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Good written and verbal communication skills are required.
Summarize and present results; experience with team‑based collaborations is a must.
Interpret problems and determine appropriate resolutions that ensure compliance and minimize risk.
Collaborate well with stakeholders, customers, and peers.
Exhibit strong decision‑making ability and think creatively while maintaining compliance and quality.
Discern the criticality of issues and communicate to management regarding complex issues.
Manage conflict and issues that arise with internal or external customers.
Salary Range USD $75,972 – $99,713
Benefits We offer a comprehensive benefits package that includes medical, dental, and vision insurance, a 401(k) retirement plan with company match (vested fully on day one), equity and stock options (for eligible roles), eight weeks of paid parental leave after three months of employment, and a paid time off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include 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, 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. Employment is at‑will and may be terminated at any time with or without cause or notice. Legend Biotech maintains a drug‑free workplace.
#J-18808-Ljbffr