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Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems.
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Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses. Analytical Development (AD) representative for cross function meetings/projects with manufacturing, Quality Assurance (QA), Regulatory Affairs and external partners.
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Support the configuration control function to include receipt, dissemination, processing, tracking, and providing recommendation for the final disposition of Advanced Change Study Notices, ECPs, Requests for Deviation/Request for Waiver, Deficiency Reports (DRs), Airworthiness Directive Notes, Service Actions, Service Bulletins, Aircraft Service Changes, Notices of Deficiency, and Quality Control Plans (QCPs.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Knows process of screw and tool design, resin characteristics, temperature control, automated feedback loops, and ancillary downstream equipment such as burst testers and slickers. Sets up and operates plastic extrusion equipment to manufacture miniature, precision tubing to established quality standards in order to meet production demands.
$54,000 a yearExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.
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Requirements: Master's degree in Regulatory Affairs, Engineering, Life Sciences, or closely related technical discipline (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or experience executing the complete lifecycle of product registrations before national and international regulatory agencies, including documenting internal processes for quality control, and coordinating post-market surveillance and reporting activities.
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Seurat’s proprietary Area Printing process, developed at Lawrence Livermore National Labs (LLNL), allows metal components to be manufactured at price points and quality levels that compete directly with conventional manufacturing techniques, enabling the reshoring of supply chains and promoting the decarbonization of industry.
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Team-oriented, customer-focused work ethic and time management skills Experience with Microsoft Office, MS Word, and MS Excel Well-developed problem solving and decision-making abilities Attitude of collaboration and desire to develop through learning Experience with metals a plus, but not required—we will train Job Description The Quality Control Inspector conducts first piece, in-process, and final inspections of parts and products throughout the entire product flow in production.
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BS in a scientific or engineering discipline with minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, with at least 2 years conducting internal and external audits.
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Conducts Quality Control process reviews and remediation as needed. Focused, quick thinker who can comfortably handle and process large quantities of data accurately and effectively.
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Utilize statistical process control (SPC) methods to analyze data and assess process performance. Design and deliver training programs on quality and manufacturing standards to key staff members.
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May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
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The individual in this role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen's services and commercial products in compliance with company policies and procedures and regulatory guidelines.
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Design and implement code for motion control and PLC systems in their native languages. Experience designing / developing GUI / HMI systems for complex control systems. Experience with software configuration management and source control systems (i.e. Mercurial/GIT.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The candidate will collaborate with the preclinical research team exploring novel technologies and with Process Development, Quality Control and CMC group to develop novel cell therapy platforms.
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quality control process jobs in Burlington, MA
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