Ert
Senior .Director Operational Quality Assurance
Luitpold Pharmaceuticals
Director, Clinical Quality Assurance
Morphotek, Inc. 2011 - Apr 2016
Director Quality Operations, Quality and Compliance Management
Adolor 2003 - 2011
Director Gxp Compliance
Centocor 1999 - 2003
Senior Manager Quality Assurance
Education:
West Chester University of Pennsylvania 1991 - 1993
Master of Science, Masters, Physiology, Virology
Saint Joseph's University 1987 - 1991
Bachelors, Bachelor of Science, Biology
Skills:
Fda Gmp Validation Glp Gxp Quality Assurance Pharmaceutical Industry Quality System Regulatory Affairs Gcp Medical Devices Quality Management Analytical Chemistry Trackwise Batch Records Batch Release Label Design Medical Diagnostics Change Management Deviation Management Capa Risk Management Logistics Pre Approval Biotechnology Good Clinical Practice Good Laboratory Practice U.s. Food and Drug Administration Corrective and Preventive Action