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Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products.
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Job Overview: This role, for a Document QC Specialist Contractor, will manage the quality control of scientific documents and Bioanalytical data for the Translational DMPK and Clinical Pharmacology group.
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Experience in the following areas preferred: Quality Controls within Manufacturing, Quality Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management.
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Provide technical and guidance in lab support to manufacturing, multiple QC laboratories and the overall Quality Organization to resolve test issues, conduct OOT/OOS investigations, identify and improve problematic methods, and drive innovation.
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Collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to assure effective tech transfers and start-up of new manufacturing processes according to agreed upon timelines in support of business objectives.
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You will report to the Executive Director, Quality Assurance at Ultragenyx Gene Therapy. As the Director, Quality Assurance Warehouse Operations you be responsible for QA oversite of the warehouse and supply chain production processes at the new gene therapy manufacturing facility located in Bedford, MA. During the construction and qualification phases this will be a critical role in establishing the quality oversight for processes such as material receipt, material release, and material management while interfacing with the ERP system.
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Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities. Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company.
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Uses Microsoft Excel to monitor release dates, and position to program need on WIP. Works with Manufacturing Supervisor, Manufacturing Engineer, Quality Engineer, Program Manager, etc. Prepare assembly kits for issue to the manufacturing floor in a manner which meets established standards of quality and schedule.
$20 - $25.91ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Acting as a one-man attachment to other special forces teams, these highly specialized Airmen are trained in a wide range of skills, including scuba, parachuting and snowmobiling, as well as being FAcertified air traffic controllers in order to establish air control and provide combat support on missions all over the globe.
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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility.
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QC Testing data review of products, raw materials, stability lots. Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
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Support the performance of the other appropriate Quality Assurance functions including document writing/revisions, deviations, CAPA's, document/data review and other administrative duties as needed.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development.
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Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Change Specialist based onsite in our Tewksbury, MA facility. Creates final original document from completed change control process.
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You'll be responsible for the operation and quality assurance of film processing, patient monitoring, and x-ray equipment. Jackson Therapy Partners is seeking a travel Interventional Radiology Technologist for a travel job in Concord, Massachusetts.
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quality control qc assurance jobs Title: quality specialist in Chelmsford, MA
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