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Kelly Science and Clinical is hiring a temporary Document Control Specialist. Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy and/or biologics. Document Control Specialist.
$30 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Handle control, issuance, reconciliation, and archiving of GMP manufacturing and testing documentation, including batch manufacturing records and logbooks. Working knowledge of ICH guidance, regulatory guidance, and pharmaceutical organization guidance.
$30 an hourFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Maintains internal change control for validated methods and regulatory documents and assists in the change control process at OTL’s. BS degree in Chemistry, Biochemistry, Molecular Biology, Virology or related scientific disciplines or equivalent experience, + 15 years of experience, 5 years of experience must be in Quality Control or cGMP laboratories.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy and biologics. GxP Document Control Specialist. Control, issue, reconcile, and archive GMP manufacturing and testing documentation, including batch manufacturing records and logbooks.
$33 an hourExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
$70 an hourFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The candidate will work closely with other functions in the Technical Operations team (External Manufacturing, Supply Chain, Process Sciences, Gene Delivery & Editing, Quality Assurance, Quality Control, CMC Operations, and CMC Regulatory) to support development of the internal and external packaging and shipping validation strategy, and execute against the strategy to ensure reliable deliverables throughout the project life cycle.
$198,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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About the Opportunity: The Associate Director of Quality Control is responsible to lead all lab operations of GMP Quality Control to ensure Codexis's production operations meet regulatory standards with respect to quality, integrity and efficiency.
$220,000 a yearExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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In order to be effective you will apply radiation detection principles, knowledge of regulatory requirements and proficiency in one or more of the following areas: radioactive material activation and contamination surveys, shipping determinations, area radiation monitoring, radiological work control development, gamma spectroscopy and liquid scintillation.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Vault QMS was recently implemented over the course of a three-year program and includes many of Veeva’s modules for managing Quality Events (Deviation, CAPA, Change Control, Lab Investigation, Complaints, Escalations, etc.
$214,280 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Coordinates the planning, promotion and organization of quality, regulatory and reliability engineering activities, including Design/Development/NPI, DHF/DMR/DHR documentation, supplier qualification, manufacturing, and distribution control.
$235,600 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Using lessons we've learned at places like SpaceX and Blue Origin, Xona is constructing a modern satellite network at the rapid pace of the new space industry leveraging the recent wave of technology and regulatory advancements.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Understanding of security control frameworks NIST, ISO, HITRUST and regulatory requirements such as SoX, GDPR, CCPA and GxP. Ensure compliance with regulatory requirements and industry best practices.
$185,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Demonstration of outcome-oriented team leadership in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory, or process development, or as part of a cross-functional product team in the broader pharmaceutical industry.
$307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead early and late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 30 days ago
control regulatory jobs in San Mateo, CA
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