Word • Excel • PowerPoint • Visio • MS Project • Lotus Notes • Outlook • Access • Business Objects • Captivate • MiniTab • Registrar Training System • MasterControl Systems • Pilgrim Quality Management Systems • Plateau Training System • Epicore and Access databas management
OmniGuide since Nov 2010
Document Control / Quality Engineer
MILLIPORE CORPORATION 2007 - 2010
Quality Systems Specialist III
Charles River Laboratories 2004 - 2007
Quality Systems Manager
Charles River Laboratories 2002 - 2004
Regualtory Documentation Supervisor
Biogen Idec (Formerly know as Biogen) 1998 - 2002
Technical Training Specialist
Education:
SQA (Society of Quality Assurance) 2006 - 2006
Professional Development Seminar, Introduction to Principles of Computer Validation
SQA (Society of Quality Assurance) 2006 - 2006
Professional Development Seminar, Advanced Concepts in Computer Validation
International Quality & Productivity Center 2003 - 2003
CPE Credits, Electronic Document Management & Publishing Solutions, Pharmaceutical
International Quality & Productivity Center 2002 - 2002
CPE Credits, Archiving & Data Management for 21 CFR Part 11, Pharmaceutical
American Management Association International 1999 - 1999
Continuing Education Units, Train the Trainer - 5 day workshop
Quinsigamond Community College 1994 - 1994
Certification, Biotechnology Technician Certification
Quinsigamond Community College 1992 - 1994
Asscociates, Liberal Arts/Biotechnology
Skills:
Fda Capa Quality Assurance Quality System Validation Gmp Quality Control Iso 13485 21 Cfr Part 11 Medical Devices Document Management Change Control Software Documentation Iso Sop Biotechnology Glp Quality Systems Cgmp Design of Experiments Cross Functional Team Leadership Manufacturing Internal Audit U.s. Food and Drug Administration External Audit Corrective and Preventive Action Computer System Validation Gamp Life Sciences Documentation Biopharmaceuticals
May 2013 to 2000 Document Control SpecialistNINEPOINT MEDICAL, INC
2012 to 2000 Document Control SpecialistOMNIGUIDE, INC Cambridge, MA 2010 to 2012 Document Control Coordinator / Quality EngineerMILLIPORE CORPORATION Billerica, MA 2007 to 2010 Quality Systems Specialist IIICHARLES RIVER LABORATORIES
2004 to 2007 ManagerCHARLES RIVER LABORATORIES
2002 to 2004 SupervisorBIOGEN IDEC
1998 to 2002 Technical Training SpecialistBIOGEN IDEC
1994 to 1998 Bioprocessing Operator, LeadSchott Fiber Optics Southbridge, MA 1986 to 1989 Quality Control Inspector and AssemblerGalileo Electro Optics Sturbridge, MA 1985 to 1986 Quality Control Inspector
Education:
International Quality & Productivity Center 2003 CPT in ManagementQuinsigamond Community College Worcester, MA 1996 Associate in Liberal ArtsQuinsigamond Community College Worcester, MA 1994 Certificate in Biotechnology in Biotechnology
Skills:
Word, Excel, PowerPoint, Visio, MS Project, Lotus Notes, Outlook, Access, Business Objects, Captivate, MiniTab, Registrar Training System, MasterControl Systems, Pilgrim Quality Management Systems, Plateau Training System, Epicore and Access databas management