Korchek Technologies
Implementation Specialist
Mission Pharmacal Jul 2012 - Mar 2014
Regulatory Affairs Project Manager
Mission Pharmacal May 2009 - Jul 2012
Technical Services Analyst
Mission Pharmacal Nov 2005 - May 2009
Quality Control Investigator
Legacy of Life Tissue Foundation 2002 - 2003
Quality Assurance Manager
Education:
Baylor University 1989 - 1994
Bachelors, Bachelor of Science, Biology
Skills:
Validation Quality Assurance Pharmaceutical Industry Regulatory Affairs Fda Quality Control Gmp Sop Capa Biotechnology Glp Software Documentation Medical Devices V&V Computer System Validation 21 Cfr Part 11 Chemistry Technology Transfer Quality Management Change Control Regulatory Submissions Quality System Technical Writing Manufacturing Regulatory Requirements Hplc Iso 13485 Raw Materials Auditing Trackwise Analytical Method Validation Biopharmaceuticals Formulation Design Control Gas Chromatography