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U.S Food and Drug Administration, Center for Devices and Radiological Health
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QA Specialist, Preclinical and Clinical
SUMMARY OF POSITION: The QA Specialist, Preclinical and Clinical Quality Assurance ensures GLP, OECD, GCP, CAP/CLIA compliance with Fulgent Therapeutics, LLC Standard Operating Procedures (SOPs), ICH, and US FDA regulations and guidelines, and Preclinical and Clinical study protocols/plans. This position interacts with functional teams in Preclinical and Clinical Trials, which include Preclinical and Clinical Operations, Product Development, GLP and Clinical Lab teams, Regulatory, Pharmacovigilance, Medical Writing, and Data Management to ensure compliance to the Quality Management System (QMS) and all applicable reg
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