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Personal Information
Organization / Workplace
Washington D.C. Metro Area United States
Occupation
Sr. Laboratory QMS Specialist at U.S. Pharmacopeia
Industry
Medical / Health Care / Pharmaceuticals
About
Quality Assurance and Compliance Specialist with 14+ years of progressive experience within the pharmaceutical/ biotech industry. Area of expertise includes assuring laboratory compliance (GLP/ GMP/ GCP/ISO/WHO) for sample testing. Specializing in auditing quality and technical operation policies and procedures to verify compliance. Experience working in virtual, international and multi-site environments with persons of varied backgrounds and cultures. Understanding of 21 CFR 11, 58, 210, 211, 820; ICH Q8, Q9, Q10; ISO 15189, 17025, and 19011.
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