
Experienced professional with over 15 years of Computer Compliance, SQA and Risk Management experience in information technology and computerized systems for the Bio-tech/ Pharma/Med Device Industry (FDA regulated environment) Specialties Include: - IT Compliance (Infrastructure Validation, Enterprise Applications, Software Deployments, etc) - Software Validation for Databases/ Application Servers, Lab Systems, Clinical, Regulatory, etc - CFR 21, Part 11 Remediation (Electronic Signatures, Audit Trails, Security, System Administration, etc) - Authoring and execution of high quality SLDC documentation - Implementing guidelines and policies to comply with applicable regulations Systems Experience Includes: - Empower Chromatography Data System (CDS) - LabVantage/Sapphire LIMS - Nautilus LIMS - Watson LIMS - IDBS E-Workbook - lifeIMAGE (cloud based medical imaging repository) - inviCRO iPACS (Imaging Study Management System) - tranSMART (Data/Analysis Repository) - Donor Management System (DMS) - Engineering Document Management System (EDMS) - SAP - Compliance Wire - Documentum - myCIMS - Sharepoint - Microsoft Office Products: Word, Excel, PowerPoint Volunteer Experience: 2016/2017 ISPE Board of Directors 2015/2016 ISPE Boston Area Product Show Chair 2014 ISPE Boston Area Chapter Volunteer of the Year Award winner in recognition and appreciation of the many contributions and outstanding dedication to the ISPE Boston Area Chapter.
pfizer.com
skillsoft.com
sequenceqcs.com
xerox.com
ppd.com
misyshealthcare.com
Greater Boston
Laboratory Applications/Instruments Validation, Administration and Support
Pfizer
• www.linkedin.com/company/pfizer
• Full-time
Aug 2017 - Present
Andover, MA
Board of Directors
ISPE Boston Area Chapter
• www.linkedin.com/company/ispeboston
Aug 2016 - Oct 2018
Boston
Sr. Validation Consultant
Sequence Inc.
• www.linkedin.com/company/sequence-inc-
Feb 2016 - Aug 2017
Confidential Client - Greater Boston Area
Business Development Regional Manager and Senior Consultant for Sequence Quality and Compliance Serv
Sequence Inc.
• www.linkedin.com/company/sequence-inc-
Dec 2005 - Aug 2017
Greater Boston Area/North East Region
Sequence Inc. - Technical Project/Validation/Business Analyst
Sequence Inc.
• www.linkedin.com/company/sequence-inc-
Dec 2012 - Nov 2015
Confidential Client - Greater Boston Area
Software Test Engineer II
Veramark Technologies
Jan 1997 - Dec 2000