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QA Shop Floor Lead

4 months ago

Raritan, United States Legend Biotech US Full time
Company Information

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 and natural killer (NK) cell-based immunotherapy.

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) in 2017. 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 Lead as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Shop Floor Lead is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule.

Key Responsibilities
  • Serve as a Quality person in plant in support of cell therapy manufacturing.
  • Collaborate with site personnel to provide guidance and determine resolution for manufacturing
    issues.
  • Ensure accurate and timely support of manufacturing investigations, CAPAs, change controls.
  • Author, review and approve documentation related to manufacturing procedures and batch records.
  • Real time review of all documentation and reporting in support of process unit operations and
    release activities.
  • Strive to reduce non-conformances in supported areas by proactively driving compliance.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP
    requirements.
  • Support regulatory inspections and audits by ensuring inspection readiness within facility.
  • Perform internal housekeeping audits.
  • Support material release in SAP for In-house reagents.
  • Perform Area Spot checks for Non-conformance.
  • Other duties will be assigned, as necessary.
  • Work on shifts to support production and cell processing.
  • Remain current on all training and compliance requirements.
  • Support clean room activities.
  • Provider QA shop floor support for extended periods of time.
  • Schedule activities for the QPIP team.
  • Leads daily closeout meetings.
Requirements
  • Education: Bachelor's Degree in Science, Engineering or equivalent technical.
  • Discipline with minimum of 2 years of experience; or a minimum of 10 years of relevant experience is
    required.
  • Experience: Must have 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.
  • Aseptic processing in ISO 5 clean room and biosafety cabinets.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based
    products as well as knowledge of Good Tissue Practices.
  • Great attention to detail and ability to follow the procedures.
  • The candidate must 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.
  • Ability to summarize and present results, and experience with team-based collaborations is a must.
  • Must be able to interpret problems and effectively determine appropriate resolutions that ensure
    compliance and minimize risk.
  • Must exhibit strong leadership skills and effectively develop others.
  • Ability to collaborate well with stakeholders, customers and peers.
  • Must exhibit strong decision-making ability and think creatively while maintaining compliance and
    quality.
  • Must be able to discern the criticality of issues and to communicate to management regarding
    complex issues.
  • Ability to manage conflict and issues that arise with internal or external customers.

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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 law.

Legend Biotech maintains a drug-free workplace.