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Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
$155,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Performs work under regulated conditions (GLP, GCP, CLIA) as required. Implements and observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements, study protocols, and analytical plans.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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To work to the Company’s quality procedures in accordance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations and be involved in working to and generating a culture of continuous improvement.
$28 - $35 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.
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Demonstrates a thorough knowledge of Good Clinical Practice "GCP", Good Pharmacovigilance Practices "GVP", Good Laboratory Practice "GLP", Good Documentation Practice "GDP" and ICH E6 R2 compliance requirements.
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Experience in a GxP preferred (GMP, Good Manufacturing Practices, GLP, Good Laboratory Practice, GCP Good Clinical Practice, GDP, Good Documentation Practice) Provide back-up assistance for Wastewater Treatment Plant operations.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Hire and provide oversight of Quality personnel with expertise in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP.
$200,000 - $250,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs.
$144,800 - $170,300 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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At least 10 years in relevant quality auditor roles in which significant exposure to GCP/GLP has occurred. Regular specific interaction also occurs with the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.
$150 - $200Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Collaborate with Quality teams to ensure compliance with regulatory standards, including but not limited to GMP, GLP, and GCP, as applicable. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.
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Coordinate the follow-up to stipulation requests to ensure Good Clinical practices (GCP) Good Laboratory Practice (GLP) according to Federal regulations; reinforce researchparticipant’s instructions in the proper technique of various selfadministered treatmentsand documents the activities performed.
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GCP and GLP experience a plus. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs.
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GxP disciplines in scope include GCP, CDx, CSV/IT, GLP, GMP, and PV. Our client is a clinical-stage biopharma company developing precision oncology medicines using its proprietary proteomics platform to develop drug-specific companion diagnostics.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GLP, GCP, GVP and GMP functions. Collaborates with internal functions and aligns goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices.
$315,000 - $320,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago
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