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.