Loc Nguyen
Senior Manager, Quality, Health, Safety, Security, and Environment @Atl, A Bureau Veritas Company
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WORK HISTORY
Senior Manager, Quality, Health, Safety, Security, and Environment @Atl, A Bureau Veritas Company
EDUCATION
University of Houston-Victoria
Master of Business Administration - MBA, Business Administration and Management, General
Miami University
Bachelor of Arts (B.A.), Chemistry
Prairie View A&M University
Master of Science - MS, Chemistry
ABOUT LOC NGUYEN
Resourceful Quality Management with progressive experiences in the pharmaceutical industry leading diverse teams in FDA (21 CFR 210,211, 820), pharmacy (503A, 503B), ICH Compliance, Quality Systems, Quality Control, Quality Assurance, analytical R&D, and aseptic injectable including combination devices manufacturing facilities. Extremely motivated with a strong work ethic.Skills:Compliance: FDA 21 CFR 210,211,820, 503A/503B Compounding, State Boards of Pharmacy, Controlled Substances, EPA, Hamilton Health Department, USP 797, ICH guidelines, ISO 17025, and A2LA.Quality: cGMP/GLP/GDP, Audit (Internal/ External), Deviation/Investigation, CAPA, Document and Record Control, and Root Cause Analysis, Batch Record Review, Supplier Program, Validation (IQ/OQ/PQ), Quality System (MasterControl, EagleTrax, Lablite, and Titan), and Product Disposition.Documentation: Procedure and Work Instruction Creation, Validation Review, Technical Writing, and Technical Reviewer. Scientific: Spectrophotometer, Wet Chemistry Analysis, USP Monographs, FTIR, HPLC, UPLC, UHPLC, QDA, and ELISA.
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