STERIS Corporation since Aug 2012
Lead Regulatory Affairs Specialist
STERIS Corporation Jul 2009 - Aug 2012
Quality Systems Manager
STERIS Corporation Jun 2004 - Jul 2009
Operations Project Manager
Gliatech 1997 - 2002
Lab technician
Education:
Case Western Reserve University 1989 - 1992
MS, Biology
Skills:
Quality System Validation Gmp Design Control Regulatory Affairs Fda Medical Devices Iso 13485 Capa Manufacturing Process Improvement Cross Functional Team Leadership Biotechnology Sterilization V&V Iso 14971 21 Cfr Quality Auditing 21 Cfr Part 11 Sop Regulatory Requirements Computer System Validation Change Control Cleaning Validation Iso Six Sigma Fda Gmp Regulatory Submissions Lims Glp Technology Transfer Life Sciences U.s. Food and Drug Administration Lean Manufacturing Cqa Continuous Improvement Root Cause Analysis Medical Device Directive Gxp Biopharmaceuticals Quality Assurance Standard Operating Procedure Corrective and Preventive Action Verification and Validation Business Process Improvement Product Development