Product Investigations (P.I.) Laboratory Assistant
Greater Atlanta Area
• Maintained the Product Investigative Lab environment according to State, National and FDA Standards• Enhanced Lab Assistant position to include testing of daily quality control reagents and monitored serological testing to identify antibodiesOrdered Lab supplies through Purchasing using various vendorso Ensured availability supplies and protective equipment for Medical Technologist• Collected weekly from the Manufacturing and Quality Control Departments each (lot number) /product released to customers for investigative testing • Documented, into Logbook, each product received; maintained inventory logbooks; documents archived when necessary • Performed Random Audits to ensure Investigation Staff followed Standard Protocol.• Assigned Deviations for Non-Compliance; P.I. Lab deviations decreased 4% each year, 2008-2011 • Due to Lab preparation, P.I. Lab passed FDA Inspections with minimum violations or warnings, 2009-20011• Prepped Lab according to International Standards for Labs (ISL); passed international audits without violations• Performed quality control and visual Inspections on Lab Inventory and client samples• Collaborate with cross functional teams to determine root causes and corrective actions for deviations• Presentation of Lab Results to Field Quality and Research & Development to improve product design• Acted as liaison between Technical Support, Field Quality, and Research & Development coordinating sample testing and research projects monthly• Daily Processed, managed, and archived 20-25 Technical Deviation Reports• Monitored daily temperature of refrigerators and laboratory sites