Wayne Berry
Education
University of Tennessee, Knoxville
, Public Administration -
Merrimack College
, Project Management -
Computer Learning Center
, C, C++, COBOL programming -
Lawrence County High School
, -Work Experience
Foundation Medicine
Current
Foundation Medicine
PSC Biotech® Corporation
2018-08-01 - 2023-03-01
PSC Biotech® Corporation
New England Biolabs
2011-01-01 - 2017-01-01
New England Biolabs
Fortelligent
2006-01-01 - 2009-01-01
Fortelligent
Trinity Pharma Solutions
2005-01-01 - 2006-01-01
Trinity Pharma Solutions
Verizon Information Services
2004-01-01 - 2005-01-01
Verizon Information Services
Dun & Bradstreet
2003-01-01 - 2003-10-01
Dun & Bradstreet
Arthur D. Little
1997-01-01 - 2002-08-01
Arthur D. Little
Harte-Hanks Data Technologies
1996-09-01 - 1997-03-01
Harte-Hanks Data Technologies
DST/BELVEDERE FINANCIAL SYSTEMS
1994-05-01 - 1996-09-01
DST/BELVEDERE FINANCIAL SYSTEMS
Skills
Summary
I am a Senior Validation Engineer and a Senior Project Manager with several years of experience in various GMP and non-GMP settings. I have 12 years of experience in the Life Sciences biotechnology industry, where my focus has been on electronic Quality Management Systems and related processes. I've performed gap analysis on paper-based systems, made recommendations for process improvement, and provided roadmaps for compliance. My skill set includes both project management expertise and hands-on experience, including authoring SOPs and Policies, performing validation, and implementing the component parts of Quality systems such as Document Management, Training, Non-Conformance Management (CAPAs, lab investigations for Out of Spec Investigations, Deviations), and Audit Management. I have a strong understanding of Annex 11 and 21 CFR part 11 for data integrity, security, and the impacts of Change Management and the Software Lifecycle (SDLC) process on electronic Quality Management Systems (eQMS). My strong Project Management and direct supervision experience (combined with technical, liaison, and resource management), has provided me with a successful track record of team building, process improvement, and project delivery. I am BRAINBENCH certified in PMBOK 1996, 2000 & 2005 methodologies, a member of the National Project Management Institute and the local Mass Bay Chapter. My varied background has given me insight into how people from different cultures, abilities, and perspectives approach accomplishing their tasks, allowing me to form successful partnerships to achieve mutual goals. I've worked in the Tech industry as a programmer/developer, in Academia implementing Quality and Knowledge Management Systems for Scientists and Researchers, and in building demolition with a multicultural team (requiring ameliorating language barriers) under stressful conditions while attending school for programming. To round out my background, I’ve also worked in the Service Sector as a customer service representative and a Bartender.
