Location:
1331 south Railroad St, Millbury, OH 43447
Work:
Exemplar Compliance
Apr 2015 - Apr 2016
Senior Consultant, Gmp Sme
Compliance Services and Solutions
Nov 2014 - Dec 2014
Senior Consultant
Tunnell Consulting, Inc.
May 2013 - Oct 2014
Senior Consultant
Britt Pharma Consulting
May 2013 - Oct 2014
President and Owner, Britt Pharma Consulting Llc
Microdose Therapeutx
Apr 2009 - Sep 2012
Director Quality Assurance
Microdose Technologies
Sep 2004 - Apr 2009
Director Quality Assurance
Cordis
Apr 2004 - Jun 2004
Senior Consultant, Cgmp Regulatory Compliance
Novartis
Jan 1997 - Nov 2003
Senior Compliance Specialist
Ciba-Geigy
Jun 1995 - Jan 1997
Head, Product Testing Quality Control Laboratory
Ciba-Geigy
Nov 1992 - Jun 1995
Senior Technical Consultant, Chemical Operations
Ciba-Geigy
Jan 1990 - Nov 1992
Manager, Chemical Operations Staff and Deputy Director
Education:
Fordham University
Doctorates, Doctor of Philosophy, Organic Chemistry
Skills:
Iso 13485, Gmp, Pharmaceutical Industry, Fda, Capa, Quality Management, Quality Systems, Change Control, Sop Development, Cmc Development, Validation, Quality Assurance, Quality Control, Quality Operations, Medical Devices, Pharmaceutics, Gxp, R&D, V&V, Quality System, Clinical Development, Sop, Glp, Cro, Computer System Validation, Clinical Trials, Cleaning Validation, Regulatory Affairs, Technology Transfer, Biotechnology, Biopharmaceuticals, Gcp, Aseptic Processing, Ind, Lifesciences, Lims, Regulatory Submissions, Regulatory Requirements, Hplc, Trackwise, Drug Delivery, Analytical Chemistry, Quality By Design, Design Control, Cmc, Iso 14971, Deviation Management, Chemistry, Laboratory, Quality Auditing
Certifications:
Asq Certified Quality Auditor (Cqa)
American Society For Quality (Asq)