Elaine R Donley

Jersey City, NJ

Pharmaceuticals

EMC - Princeton, NJ since Jun 2013
Sr Consultant (IIG - Information Intelligence Group)
Sitrof Technologies, Inc. - Princeton, NJ Oct 2011 - Jun 2013
Senior Business Analyst, IT
Teva Pharmaceuticals - Woodcliff Lake, NJ Oct 2007 - Dec 2010
Business Analyst, IT Compliance & Validation
Pfizer - Morris Plains, NJ May 2003 - Dec 2006
Associate, Worldwide Regulatory Operations; SOP Systems Specialist, QA
Hoffmann-La Roche - Nutley, NJ Mar 2000 - May 2003
Engineer, Quality Assurance; IT Systems Analyst, Information Management

Richard Stockton College of New Jersey
Bachelor of Science, Chemistry Temple University
Master of Science, Quality Assurance / Regulatory Affairs

Quality Assurance
21 Cfr Part 11
Validation
Change Control
Computer System Validation
Fda
Software Documentation
Gmp
Sdlc
Gxp
Pharmaceutical Industry
Capa
Cross Functional Team Leadership
Process Improvement
Sop
Quality System
Business Analysis
Lims
Quality Auditing
Document Management
Integration
Project Management
Process Simulation
Regulatory Affairs
Business Process
R&D
Management
Risk Assessment
Testing
V&V
Leadership
Sap
Sharepoint
Gcp
Glp
Project Portfolio Management
Quality Control
U.s. Food and Drug Administration
Gamp
Quality Management
Sop Development
Regulatory Requirements
Visio
Documentum
Lifesciences
Manufacturing
Business Process Improvement
Standard Operating Procedure
System Administration