Vice President of Quality
Sr. Research Analytical Chemist performing nucleotide triphosphate, amidite, and drug development assay analysis via HPLC, GC, Mass Spectroscopy, NMR, ICP. Performed protein purification via FPLC produced in large Pfaudler reactors. Follow USP, FDA, and microbiological BAM/AOAC methodologies to perform and implement all micro analysis.
Expert operations, quality management, procurement, and food/drug safety professional with extensive experience in laboratory and manufacturing operations following state and federal regulations. Lead negotiator, communicator, and process trainer. Executive Management Team member for onboarding project preparation and strategic business management. Successfully develop and implement divisional FDA/USDA food safety/Regulatory plans/HACCP plans.
Build complete Quality Management and Food Safety Programs to include creating and implementing Standard Operating Procedures, work Instructions, setting raw material and finished product specifications, developing process controls statistically, validating finished product acceptance limits, and training staff to competency. Data analysis via SPC data plotting, dashboard and trend reporting. Develop process preventive controls, perform extensive risk analysis, and Food Safety Plans. Create and implement Laboratory, Production, Quality, and Sanitation verification and validation protocols. Standard Process development and staff training in all critical processes.