Rxbio, Inc Oct 2012 - Mar 2017
Quality Affairs Director
Us Compounding Oct 2012 - Mar 2017
Director of 503 Quality
Cetero Research Sep 2011 - Oct 2012
Director, Bioanalytical Quality Assurance
Cetero Research Jun 2010 - Sep 2011
Director, Investigations and Process Improvements
Cetero Research Jul 2009 - Jun 2010
Director, Bioanalytical Operations
Education:
University of Oregon 1983 - 1988
Bachelors, Bachelor of Science, Chemistry
American School In London
Skills:
Fda Change Control Biotechnology Gmp Quality Assurance Pharmaceutical Industry Capa 21 Cfr Part 11 Quality Control Pharmaceutics Vaccines Quality System Sop Gxp Lims V&V Standard Operating Procedure Technology Transfer Aseptic Processing Glp Regulatory Requirements Laboratory Information Management System Good Laboratory Practice Software Documentation Cleaning Validation Regulatory Affairs Chromatography U.s. Food and Drug Administration Uv/Vis Computer System Validation Biopharmaceuticals Analytical Chemistry Corrective and Preventive Action Validation Regulatory Submissions Verification and Validation Microbiology Laboratory Hplc High Performance Liquid Chromatography