Analytical Development Compliance Manager @ (November 2015 - October 2020)
Project Lead, Principal Scientist @ (June 2014 - July 2015)
Team Leader, R and D Quality and Compliance @ (September 2003 - June 2014)
Self-Inspection Program Leader @ (September 2003 - October 2006)
Manager, Corporate QA @ (July 2002 - September 2003)
Research Scientist III @ (January 1999 - January 2002)
Pharmaceutical Analysis Chemist @ (March 1996 - February 1999)
Chemist @ Schein Pharmaceuticals (January 1995 - March 1996)
Colleen Grace Education
Temple University
MS (Quality Assurance & Regulatory Affairs)
2004-2007
University of Michigan
BS (Biology)
1989-2003
BA High School 1986-1989
Colleen Grace Skills
Pharmaceutical Industry
Quality Assurance
Validation
GMP
FDA
GxP
LIMS
Clinical Trials
Instructional Design
Computer System Validation
GCP
SOP
Change Control
Investigation
CAPA
Regulatory Compliance
Compliance Management
Project Management
Stability Programs
Supervisory Skills
Regulatory Documentation
Standard Operating Procedure (SOP)
Analytical Chemistry
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Laboratory Information Management System (LIMS)
Corrective and Preventive Action Capa
Laboratory Information Management System Lims
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Standard Operating Procedure
Corrective and Preventive Action
u.s. Food and Drug Administration
Laboratory Information Management System
Colleen Grace Summary
Colleen Grace, based in Horseheads, NY, US, is currently a Associate Director, QA Compliance at XGen Pharmaceuticals DJB. Colleen Grace brings experience from previous roles at Pharmalucence, Bayer, Merck Consumer Care and Schering-Plough Research Institute. Colleen Grace holds a 2004 - 2007 MS in Quality Assurance & Regulatory Affairs @ Temple University. With a robust skill set that includes Pharmaceutical Industry, Quality Assurance, Validation, GMP, FDA and more. Colleen Grace has 1 emails and 1 mobile phone numbers on RocketReach.
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