Quality Assurance Specialist @ (October 2009 - February 2016)
QA Manager @ (August 2008 - September 2009)
Documentation Manager @ (March 2005 - August 2008)
Documentation and Training Manager @ (January 2004 - March 2005)
Documentation and Regulatory Compliance Manager @ (February 2001 - January 2004)
Documentation and Records Supervisor @ (August 1999 - February 2001)
Document Control Coordinator @ DEPUY ORTHOPAEDICS, INC. (March 1997 - August 1999)
Diana Auclair Skills
Key Performance Indicators
Master Data
Documentation Control
Communication
Software Testing
Compliance Regulations
Continuous Improvement
SOP Development
Microsoft Office
Computer System Validation
Compliance Management
Electronic Signatures
Software Quality Assurance
GxP
Regulatory Compliance
Data Management
Quality Management
Change Management
QMS Implementation
Electronic Document Management System (EDMS)
eLMS Implementation
Contract Review
Lotus Notes
Team Leadership
Project Management
Audit Support
Documentation
Records Retention Management
People Management
Engineering Change Control
Master Control Administrator
Records Management
Training
FDA GMP
External Audit Support
Manufacturing Suppport
Microsoft Word
Research
PowerPoint
Sales
Quality Assurance
Medical Devices
SOP
Biotechnology
CAPA
Quality System
FDA
GMP
Validation
Cross-functional Team Leadership
Change Control
Pharmaceutical Industry
21 CFR Part 11
Management
U.S. Title 21 CFR Part 11 Regulation
Microsoft Outlook
Veeva
Master Control
Documentum
SAP ERP
Compliancewire
System Administration
System Implementations
Document Management
Diana Auclair Summary
Diana Auclair, based in Leominster, MA, US, is currently a QMS Manager at Infinity Pharmaceuticals. Diana Auclair brings experience from previous roles at ANIKA THERAPEUTICS S.R.L., Jabil Healthcare, Foundation Medicine and Siemens Healthcare Diagnostics. With a robust skill set that includes Key Performance Indicators, Master Data, Documentation Control, Communication, Software Testing and more. Diana Auclair has 1 emails and 1 mobile phone numbers on RocketReach.
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