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Interface with other departments (e.g., IT, Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of FDBC’s objectives relating to computerized system validation and associated activities, including compliance with all applicable standards.
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Oversee Document Control and lead Change Control (formulas, raw materials, and packaging materials) systems. Primary Job Responsibilities: Responsible for all aspects of company Quality Assurance and Regulatory affairs in compliance with local, state, and federal food safety standards at our dietary supplement manufacturing facility.
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The incumbent works closely with Manufacturing Operations, Engineering, Facilities, Quality Control, Microbiology, Process Development, Supply Operations, Analytical R&D, Clinical and Regulatory Affairs.
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The Principal Regulatory Affairs Specialist is responsible for participating on design control projects, evaluating document change orders for RA assessment, evaluating design change forms for RA assessment, drafting regulatory submissions, review and sign off on Regulatory/Quality documents, i.e., NCRs, CAPAs, PRAs, etc.
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In operations department, we work closely with regulatory affairs, quality assurance, other manufacturing plants and engineering to develop and implement strategies for improving existing and new products and processes.
$72,000 - $110,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with the Quality Assurance team to implement and maintain quality management systems, including document control, change control, and deviation management.
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Quality Assurance Support: Collaborate with the Quality Assurance team to implement and maintain quality management systems, including document control, change control, and deviation management.
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2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function. Provides consultation/advice to regulatory specialist for change control and product development.
TemporaryExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc. Knowledgeable in various areas of equipment and computerized systems with strong understanding of data integrity, life cycle approach, and change control management.
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This role will liaise between Systems Engineering, Technical Product Support, R&D, site-level Operations, Quality Assurance, Regulatory Affairs, and outside suppliers/vendors. 6+ years in the Biotechnology industry with a significant focus in research and development, process design and development, and/or operations/design change control plus PHD in related field of study.
$83,000 - $166,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Provide process engineering support for required equipment upgrades and or modifications and champion these efforts including writing and directing all change control activities/ deviations as required by our Quality Systems, OSHA etc.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Support the Quality Engineering group with documentation and validation needs. Bachelor’s Degree and 5+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations.
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Typical degree in Biological Sciences, Chemistry, Engineering, Computer Science and/or Regulatory Affairs or another related field. Developing/implementing tasks associated with plant activities or projects of general complexity within planned schedules/timelines, supporting audits, trending and reporting on product data, participating on teams, ensuring documentation compliance, processing complaints, CAPAs, change control, and deviations.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Recent experience with medical devices design controls; understanding of engineering change control process, familiarity with Agile PLM system. Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs.
$40 - $45 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Collaborates with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
$178,029 - $201,346 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago
affairs change control quality engineering jobs
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