Accomplished quality professional with over 20 years of experience in quality control analytical testing, approving, staff training, performing investigations, equipment validation, forensics testing, subject matter expert (SME) role and direct interaction with FDA and international regulatory agencies. Able to take on challenges and work in teams to assess, communicate, and focus on obtaining a resolution.  Extensive analytical and microbial testing knowledge with instrument troubleshooting skills. Subject Matter Expert (SME) status on numerous technology types and represented Amgen Inc, Thousand Oaks as the SME for Bioburden and Bacterial Endotoxin Testing (BET).