Amgen Mar 1, 2007 - Dec 2015
Specialist Contract Manufacturing Quality
Takeda Pharmaceuticals Mar 1, 2007 - Dec 2015
Senior Manager, Global Audit and Compliance
Amgen Apr 2003 - Mar 2007
Manager and Specialist Cgmp Qal Biochemistry Release Laboratory
Springborn Smithers Laboratories Aug 2002 - Apr 2003
Cgmp Quality Assurance Manager
Omega Pharmservices, Inc. Feb 2001 - Aug 2002
Laboratory Manager, Cgmp Analytical Laboratory
Education:
Rhode Island College
Bachelors, Bachelor of Arts, Chemistry
Skills:
Change Control Validation Gmp Quality Assurance Biotechnology Capa Lims Pharmaceutical Industry Technology Transfer Glp Quality System Biopharmaceuticals Microsoft Office Karl Fisher Hplc Trackwise Sap Aseptic Technique Dissolution Ftir Uv/Vis Sds Page Capillary Electrophoresis Stability Studies Analytical Method Validation Regulatory Submissions Analytical Chemistry Visio 21 Cfr Part 11 Aseptic Processing Biochemistry Cleaning Validation Elisa Gxp Laboratory Microbiology Standard Operating Procedure Kt Problem Solving Cgmp Auditing Trained Facilitation Ms Visio Turbochrom Hp Chemstation Millenium Mli and Anderson Impactor Analysis U.s. Food and Drug Administration Life Sciences Pharmaceutics
Brooklyn Public School 197 Brooklyn NY 1968-1970, Acorn Community High School Brooklyn NY 1970-1974, Brooklyn Friends High School Brooklyn NY 1974-1976, Linden Hill School Hawthorne NY 1977-1980, Hawthorne Cedar Knolls High School Hawthorne NY 1977-1980
Community:
Debbie Fox, Debra Hase, Angela Milea, Patricia Scanlon, Susan Braverman
Louise Tessier, Francois Gagnon, Jean Amireault, Raymond Patry, Denyse L'anglais, Lise Beauregard, Monique Mailloux, Lucille S, Pierre Vachon, Georges Latour, Mireille Pelletier