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For the Senior Validation, Engineer level: Working knowledge of target systems, including computerized information systems, manufacturing control systems (e.g., PLC, BMS, DCS, and SCADA systems), and laboratory automation systems (e.g., robotic systems, chromatography networks, data acquisition systems.
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Research, monitor, track, analyze, and disseminate internally new opportunities from DFAT, Global Fund, USAID, CDC, FDA, NIH, ASPR, Gates Foundation, GAVI, FCDO, EU, and/or other funding agencies.
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Collaborate with federal task leader to learn and employ multiple techniques involved in RNAi and CRISPR assay development and validation for various projects, including but not limited to sterile cell culture technique, qRT-PCR, reporter cell-based assays, enzyme assays, and culturing complex 3D models such as organoids.
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With employees in 13 states, and a 26-year partner to U.S. government agencies including the National Institutes of Health (NIH), Food and Drug Administration (FDA), Department of Homeland Security (DHS), Department of Justice (DoJ), and the Department of Commerce (DoC.
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Experience within Federal Government, such as DHS, FDA, NIH, or HHS is highly preferred. As a Program Manager, you will be accountable for directing customer support services, engineering, program management/ Project Management Office (PMO) and strategic support activities across all aspects of the program, including Service Desk, Deskside/ White Glove Services, systems engineering, Low Code/ No Code, DevSecOps, Automation, Hybrid cloud infrastructure, and cybersecurity, engineering.
$122,200 - $220,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Participating in activities to the delivery acoustic STDA capabilities which include one or more of the following: Requirements Definition, Funding Requirements; Analysis and Engineering; System Analysis and Design; System Integration and Test; Validation and Verification; System and Operational Performance Analysis; and Decision Analysis and Resolution.
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In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (FDA/ CBER.
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Candidate’s responsibilities will include, but will not be limited to:Managing the delivery of STDA requirements as a member of an Integrated Product Team. Participating in activities to the delivery STDA capabilities which include one or more of the following: Requirements Definition; Analysis & Engineering; System Analysis & Design; System Integration & Test; Validation & Verification; and System & Operational Performance Analysis.
$68,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Working knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is required. Contribute to the development, validation, and implementation of ligand-binding assays (LBA) for quantifying biotherapeutic proteins, biomarkers, and assessing immunogenicity in both regulated and non-regulated environment.
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High school diploma or equivalent with three years or more meat and/or seafood industry (as appropriate) FSQA Leadership experience at a federal CFIA/FDA meat and/or seafood processing plant, or a Bachelor's degree in Animal Science, Food Science, or Biological Science from four-year college or university with one or more years meat and/or seafood industry (as appropriate) FSQA Leadership at a federal CFIA/FDA meat and/or seafood processing plant.
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Complies with all CMS, USDA, FDA, DOH, OSHA regulations, and other local, state, and federal government regulations and codes as applicable. The Registered Dietitian Nutritionist will have the opportunity to impact seniors at this Maryland community through implementation of innovative dining and nutrition related programming.
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Knowledge of regulations, policies and reporting relevant to the protection of human subjects in clinical trials: GCP, IRB, FDA, SAE reporting, IND applications. 3 + years of experience in clinical research and/or bioethics with preferred experience directly related to safety & pharmacovigilance.
$100,000 - $150,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Direct experience working with or for a health agency such as: SSA, HHS (i.e. CMS, NIH, FDA, CDC), VA or DHA. Experience (at least 5 years) in three of the following areas, with Expertise in at least one: Networking, System Development, Software or Application Development, AI/ML, Data Science, Data Warehousing, Data Governance, Hardware Engineering, Operations, System Architecture, Cloud Architecture, Electronic Health Records, Information Assurance or Cyber Security, ITIL Framework, Agile Development, Health System Interoperability, and Life Sciences.
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One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial.
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You will also support internal Risk Adjustment Data Validation (RADV) monitoring programs and audits, interpret statistical analyses to enhance quality and population health, and collaborate with provider leadership to maintain and enhance risk adjustment accuracy.
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fda validation jobs in Rockville, MD
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