Maintained Good Laboratory Practices (GLP) in a pre-clinical contract research organization providing services for the biotechnology, pharmaceutical and medical device industries• Acted as lead auditor on nonclinical laboratory studies; performed critical phase inspections of ongoing study activities. Maintained electronic files to support audit activities and events.• Audited protocols, final reports, raw data and supporting electronic documentation for internal accuracy, consistency, and conformance with appropriate regulations (FDA, OECD, MHLW, ICH guidelines)• Prepared and issued reports of observations noted during report and data audits and in-process inspections• Performed inspections of all departments involved in study activities and cross -department processes. Identified compliance gaps in processes, systems and studies; provided risk-based compliance opinions and guidance to department and testing facility management.• Reviewed study incident/deviation reports to ensure effective corrective and preventative action (CAPA) was identified and implemented

Oversaw compliance and process improvement for a specialized Good Manufacturing Practice (GMP) facilty and Clinical Laboratory Improvement Amendment (CLIA) laboratory • Tracked, trended and reported monthly quality system metrics• Developed and chaired a bimonthly quality improvement meeting, the Q4 (Quality for Patients, Processes, Products and Personnel) attended by staff and managerial personnel which focused on error prevention and process evaluation topics• Initiated the use of educational process improvement case studies for the review of all staff• Participated in monthly quality improvement meetings with key hospital customers as well as meetings with other blood center departments, resulting in fewer reportable incidents with expedited resolutions• Developed a departmental Quality Plan detailing responsibilities and management for all critical processes

Provided technical support and regulatory compliance as a Subject Matter Expert for both clinical diagnostic products and automated and semi-automated analytical equipment to Blood Centers and hospital based blood banks/transfusion centers in an 8-state Western area. •Conducted implementation of semi-automated and automated blood bank equipment according to Good Manufacturing Practices (GMP), Clinical Laboratory Improvement Amendment (CLIA) and the Standards for Blood Banks and Transfusion Services requirements.•Guided clinical laboratory through the instrument validation process. Provided assistance in all aspects of preparation and planning, including operational qualification (OQ), performance qualification (PQ), laboratory information system (LIS) interfacing, and standard operating procedure (SOP) revision assistance.•Provided comprehensive technical training to over 1000 laboratory professionals through individual and group trainings during implementation