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The Senior Specialist of Quality Assurance (QA) Lot Disposition is a full-time position located at the BMS Cell Therapy Manufacturing Plant (Jump) in Bothell, WA. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements.
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The QA Specialist is responsible for all aspects of Quality Assurance related to internal processes and manufacturing activities that will take place within the DFI cGMP Facility.
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The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
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The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval and real time monitoring/approval of manufacturing activities.
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Audits the fresh DF in accordance with FDA cGMP guidelines, the DF Food Safety Plan as it pertains to the Preventive Control Rule, and the DF Seafood HACCP plan, with oversight of the QA Supervisor.
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Job Family:Research Analyst (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do:We are currently searching for a Quality Assurance Specialist to provide support to the National Institutes of Health (NIH.
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Immediate need for a talented QA Associate Specialist – Document Control. Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles Position Reports to Jenna Walker – Associate Director, QA Training & Document Control Education: Bachelor’s degree or equivalent Key Requirements and Technology Experience: Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
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Cell Therapy Document Control Specialist (NJ) Cell Therapy Document Control Specialist. Position Reports to Jenna Walker – Associate Director, QA Training & Document Control. Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
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The QA Manager/TL is accountable for ensuring cGMP compliance within the site’s B1 Biological ABI/BPM/ Pharmaceutical and Pharma/Biopackaging Operations, is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives.
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Cell Therapy Document Control Specialist (WA) Cell Therapy Document Control Specialist (WA) Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
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The Duchossois Family Institute (DFI) at the University of Chicago seeks a Quality Assurance Specialist for our current Good Manufacturing Practices (cGMP) facility. Quality Assurance (QA) Specialist page is loaded.
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On-Board Scientific is hiring a QA Associate Specialist - Document Control in Bothell, WA! Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for BMS Jump site records management.
$50.99 an hourFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance.
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Legend Biotech is seeking QA Document Control Specialist as part of the Quality team based in Raritan, NJ. The Quality Assurance Document Control Specialist role is an exempt position responsible for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.
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Innova Solutions is immediately hiring for a QA Associate Specialist - Document Control. The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
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