Position:
Quality Assurance IT Manager at United BioSource Corporation
Location:
Greater Philadelphia Area
Industry:
Pharmaceuticals
Work:
United BioSource Corporation - Blue Bell, PA since Jun 2013
Quality Assurance IT Manager
Jacquette Consulting Feb 2011 - May 2013
Senior Consultant
Pfizer - Collegeville, PA Jul 2005 - Jul 2010
Vendor Quality Manager
Octagon Research Solutions Jun 2004 - Jul 2005
Validation Manager
First Consulting Group Feb 2000 - Jun 2004
Software testing, validation
Education:
Walden University 2008 - 2015
Rutgers, The State University of New Jersey-New Brunswick 1993 - 1997
Skills:
Quality Assurance
Software Quality Assurance
Computer Systems Validation
21 CFR Part 11
GCP
Quality Auditing
Public Speaking
Public Health
Epidemiology
Pharmacoepidemiology
Compliance Audits
Vendor Qualification
Vendor Management
Relational Databases
Change Control
Quality Management
Vendors
Computer System Validation
Honor & Awards:
Panel member, Validation of SaaS webinar, 2011
Advisory board member, IIR Partnering with Labs Annual Meeting East, September 2010
Advisory board member, IIR Partnering with Labs Annual Meeting West, February 2010
Presenter, “Quality Assurance and Quality Control in Lab Outsourcing”, IIR Partnering with Labs Annual Meeting, January 2009
Panelist and presenter, “Outsourcing 101 for Small and Mid-Sized Pharma”, IIR Partnering with Labs Annual Meeting, January 2008
Presenter, “Validation of Clinical SAS Programs: A Risk-Based Approach”, Drug Information Association 20th Annual Clinical Data Management Meeting, April 2005
Author, “The Changing Face of Clinical IT”, Contract Pharma, May 2005
Author, “Risk-Based Validation: What is it and why do we do it?”, Frontline (Octagon Research Solutions quarterly client-facing newsletter), Winter 2005
Author, “Validation of Clinical SAS Programs: A Risk-Based Approach”, Pharmaceutical Formulation and Quality, Dec 2004/Jan 2005
Awards:
Award for Exceptional Achievement
Dale Carnegie Institute
