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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.
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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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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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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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The Sr Associate, Manufacturing will successfully inform, influence, and assign accountability to members of cross-functional teams that include; Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
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Lead and interface with team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines.
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Ensures project compliance to company policies and quality directives, including change control, validation, and NC/CAPA. + Develops project objectives by creating/reviewing project proposals and plans and conferring with plant management and other company stakeholders including Commercial, Regulatory, Medical Affairs, R&D, and Quality.
$70,000 - $108,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
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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.
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Track and trend quality data for non-conformances, RCI, CAPA and Change Control.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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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.
$95,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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Strong experience with network change-management control policies, and LAN and WAN troubleshooting skills and an understanding of network security best practices. Build automation and quality control checks to alert operators of any ongoing issues with existing live streams.
Full-timeExpandApply NowActive JobUpdated 15 days ago
regulatory affairs change control quality engineering jobs
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