Avram Corporation Sep 1, 2015 - Aug 2017
Director, Public Health Services
Cmc Turnkey Solutions Sep 1, 2015 - Aug 2017
Chief Operations Officer
Xellia Pharmaceuticals Feb 2016 - Mar 2016
Qa Contractor
Royal Chemical Jun 2014 - Sep 2015
Director of Quality
Amresco Llc Jun 2013 - May 2014
Manager, Qa
Education:
Gonzaga University 2010 - 2011
Saint Louis University 1993 - 1999
University of Missouri - Saint Louis 1984 - 1989
Master of Science, Masters, Bachelors, Bachelor of Arts, Chemistry
Skills:
Validation Gmp Quality Control Glp Pharmaceutical Industry Quality Assurance Fda Sop 21 Cfr Part 11 Laboratory Capa Quality System Technology Transfer Biotechnology Fda Gmp Aseptic Processing Change Control Lims Pharmaceutics Regulatory Affairs Project Management Medical Devices Good Laboratory Practice V&V Biopharmaceuticals Lean Manufacturing Analytical Chemistry Six Sigma U.s. Food and Drug Administration Aseptic Technique Contract Manufacturing Standard Operating Procedure Corrective and Preventive Action Usp Cleaning Validation Gxp R&D Hplc Regulatory Submissions Lyophilization Laboratory Information Management System Gamp Iso 9001 Iso 13485 Laboratory Skills Analytical Method Validation Trackwise Cqm Iso 17025
Certifications:
Asq - Certified Manager of Quality / Organizational Excellence Pmp - Project Management Professional