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Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.
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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.
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Execute elements of Design Control Improvement Plan and Risk Management Improvement Plan. Work with departments to discuss system gaps, fixes, design solutions and risks using Quality auditing, CAPA. Provide concise updates of critical projects to senior management.
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Build process control systems on Programmable Logic Controllers (PLCs) to operate our water electrolysis plants safely and reliably. We are looking for a Senior Control Systems Engineer to join our team.
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Implement and configure Enovia modules according to business needs, including but not limited to Product Data Management (PDM), Change Management, and Engineering BOM Management. Develop and maintain documentation, including system configurations, user guides, and training materials.
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School Crossing Guard in Belmont-Redwood Shores School District AreaAll City Management Services has immediate openings for dedicated individuals to join our team that is committed to Keeping Kids Safe as they walk to and from school every day.
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The Clinical Laboratory Supervisor will also perform high complexity laboratory testing on patient specimens, interpret and report patient results, and perform quality control and quality assurance procedures while complying with all applicable local, state, and federal laboratory requirements.
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10 years of experience creating and maintaining software for a clinical diagnostic product (CLIA or FDA), following quality system/design control system in medical. Directs the activities of the Lab Software group supporting multiple laboratory information management systems (LIMS and LIS) implementations and web application development, including.
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In the Ford Advanced Driver-Assistance Systems (ADAS) program, Ford’s team designs and develops functional models and hardware that provide best-in-class performance for features like adaptive cruise control, automatic emergency braking, cross traffic alert, active park assist and 360 camera systems.
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The candidate will be reporting to VP of Quality Assurance and is responsible for the strategic development and management of QA operations to support CMC operations and clinical activities in compliance with FDA, ICH, EMA regulations, guidances, industry standards, and company policies.
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Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST) Outsourcing, Clinical Operations, and Data Management) to ensure efficient execution of the study biomarker strategy.
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What You will do:Develop schematics comprised of FPGAs, SoCs, memories, communications devices, analog devices, ADCs, DACs, motion control devices, feedback sensors, power supplies. Aid layout designers in the layout process, applying your skills to achieve optimal placement, routing, PCB stackup, signal quality, manufacturability, and cost.
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Additional skills include assay development, knowledge of DNA analysis software, such as Vector NTI, and experience with database management. Duties will primarily involve lab work, data analysis, along with sample and database management.
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Including Zoom, MS Teams Rooms Systems, Live Events/Webinars, Digital Signage hardware & CMS, video distribution, audio DSPs and AV control systems. Working knowledge of Crestron, AMX, Medialon control systems; Biamp, Ashly, Symmetrix, Crestron, and/or QSC audio DSPs (certifications a plus.
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The Sous Chef is responsible for managing and assisting in preparing mise-en-place for all stations, expediting service, and handles staff scheduling, product ordering and inventory, and labor/cost control.
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inventory management materials quality control jobs Company: Steel Technologies in Belmont, CA
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