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QA Shop Floor Lead (2nd and 3rd shift)
Location:
Raritan, NJ
Description:
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 commercialrequirements in a sterile GMP environment. Job duties are performed within a team according to anassigned, 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 manufacturingissues. 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 andrelease 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 cGMPrequirements. 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 isrequired. Experience: Must have relevant working experience in an aseptic manufacturing facility, preferablyin 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 basedproducts 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 positiveattitude 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 ensurecompliance 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 andquality. Must be able to discern the criticality of issues and to communicate to management regardingcomplex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-JK1#LI-Onsite
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More About this Listing: QA Shop Floor Lead (2nd and 3rd shift)
QA Shop Floor Lead (2nd and 3rd shift) is a Quality Assurance QA Job at Legend Biotech USA located in Raritan NJ. Find other listings like QA Shop Floor Lead (2nd and 3rd shift) by searching Oodle for Quality Assurance QA Jobs.
QA Shop Floor Lead (2nd and 3rd shift) is a Quality Assurance QA Job at Legend Biotech USA located in Raritan NJ. Find other listings like QA Shop Floor Lead (2nd and 3rd shift) by searching Oodle for Quality Assurance QA Jobs.