Amgen - Thousand Oaks since Jan 2013
Quality Assurance - Clinical Small Molecule API
Dendreon - Seal Beach, California Mar 2011 - Jan 2013
QA Supervisor - Quality Systems
Emergent BioSolutions - Lansing, Michigan Area Oct 2008 - Mar 2011
Quality Assurance (QA) Supervisor
Emergent BioSolutions - Lansing, Michigan Area Apr 2007 - Oct 2008
Quality Assurance Quality Systems Change Control Lead
Emergent BioSolutions - Lansing, Michigan Area Oct 2004 - Apr 2007
Quality Assurance Quality Systems Deviation Investigation & CAPA Specialist
Education:
Michigan State University 2005 - 2012
Professional Master of Science, Biomedical Laboratory Operations
Eastern Michigan University 2000 - 2002
B.S., Sports Medicine - Physiology
Skills:
Capa Change Control Quality Assurance Quality System Gmp Validation Sop Aseptic Processing Fda Deviations Lims Vaccines Computer System Validation Quality Management Investigation Change Management Training Sap Root Cause Analysis Batch Release Biologics Powerpoint Performance Management Ich Guidelines Team Building Visio Document Review Process Flow Charts Gap Analysis Constraint Analysis Theory of Constraints Bridging Gaps Cycle Time Reduction Risk Assessment Effectiveness Capacity Assessment Oversight Coaching Ispe Metrics Reporting Situational Leadership Behavioral Interviewing Readiness Evaluation Microsoft Word Microsoft Excel Presentations Pilgrim Sharepoint