BioSpace
QA Shop Floor Specialist
Legend Biotech is a global biotechnology company dedicated to treating and curing life‑threatening diseases. The QA Shop Floor Specialist will be part of the Quality Operations team based in Raritan, New Jersey, providing quality oversight for the production of autologous CAR‑T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
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 address manufacturing quality issues and determine immediate action plans.
Review documentation in accordance with Good Documentation Practices (GDP).
Revise or draft Standard Operating Procedures (SOPs).
Support aseptic process simulations, commercial & clinical manufacturing, and miscellaneous runs to ensure sterility is not compromised.
Support batch review and material release in SAP for in‑house reagents.
Conduct floor spot‑checks and audit trail reviews.
Drive proactive compliance to reduce non‑conformances.
Provide quality and compliance input for continuous improvement and remediation investigations.
Approve printed labels and documents prior to use on the manufacturing floor.
Utilize electronic quality systems, batch records, and SAP.
Work in a cross‑functional team environment to meet business objectives.
Aseptically gown for Grade B clean rooms and practice aseptic behavior in controlled areas.
Support regulatory inspections and audits as needed.
Perform tasks in adherence with safety policies, quality systems, and cGMP requirements, including state and federal regulations.
Perform other duties as assigned and handle exposure to biological materials and hazardous chemicals.
Meet visual acuity and color perception requirements.
Collaborate with quality counterparts across Manufacturing 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.
Rough experience in an aseptic manufacturing facility, preferably in quality assurance or clinical quality.
Experience with quality support in clinical manufacture is preferred.
Flexible to work weekends as needed.
Mobile and able to transport between various sites.
Strong interpersonal and communication skills.
Ability to stand, walk, bend, stoop, and lift 20 lbs, and report to work on time.
Adherence to on‑site performance, including attending meetings and following safety rules.
Proficient with SAP, electronic batch records (EBR), MS Office, and relevant manufacturing applications.
Good understanding of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Strong attention to detail, organizational abilities, and competence in working independently.
Proficiency in problem solving, decision making, and risk minimization.
Ability to communicate complex issues to management and stakeholders.
Benefits Legend Biotech offers 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, flexible spending and health savings accounts, life and critical illness insurance, disability coverage, legal assistance, and additional programs. Benefits are available only to permanent employees.
Base Pay $75,972 – $99,713 USD
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. 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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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 address manufacturing quality issues and determine immediate action plans.
Review documentation in accordance with Good Documentation Practices (GDP).
Revise or draft Standard Operating Procedures (SOPs).
Support aseptic process simulations, commercial & clinical manufacturing, and miscellaneous runs to ensure sterility is not compromised.
Support batch review and material release in SAP for in‑house reagents.
Conduct floor spot‑checks and audit trail reviews.
Drive proactive compliance to reduce non‑conformances.
Provide quality and compliance input for continuous improvement and remediation investigations.
Approve printed labels and documents prior to use on the manufacturing floor.
Utilize electronic quality systems, batch records, and SAP.
Work in a cross‑functional team environment to meet business objectives.
Aseptically gown for Grade B clean rooms and practice aseptic behavior in controlled areas.
Support regulatory inspections and audits as needed.
Perform tasks in adherence with safety policies, quality systems, and cGMP requirements, including state and federal regulations.
Perform other duties as assigned and handle exposure to biological materials and hazardous chemicals.
Meet visual acuity and color perception requirements.
Collaborate with quality counterparts across Manufacturing 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.
Rough experience in an aseptic manufacturing facility, preferably in quality assurance or clinical quality.
Experience with quality support in clinical manufacture is preferred.
Flexible to work weekends as needed.
Mobile and able to transport between various sites.
Strong interpersonal and communication skills.
Ability to stand, walk, bend, stoop, and lift 20 lbs, and report to work on time.
Adherence to on‑site performance, including attending meetings and following safety rules.
Proficient with SAP, electronic batch records (EBR), MS Office, and relevant manufacturing applications.
Good understanding of cGMP regulations, FDA/EU guidance, and Good Tissue Practices.
Strong attention to detail, organizational abilities, and competence in working independently.
Proficiency in problem solving, decision making, and risk minimization.
Ability to communicate complex issues to management and stakeholders.
Benefits Legend Biotech offers 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, flexible spending and health savings accounts, life and critical illness insurance, disability coverage, legal assistance, and additional programs. Benefits are available only to permanent employees.
Base Pay $75,972 – $99,713 USD
EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. 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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