Management Quality
Resume:
Thomas J. Flahive
Hillsborough, NJ 08844
********@*****.***
SUMMARY:
Documentation Experience:
Prepared Quality documentation for, and performed some of the processes as follows:
• High-level Systems Management documents (Quality Manual, Policy)
• Standard Operating Procedures (SOPs)
• Validation: Installation Qualification (IQ), Operational Qualification (OQ), Performance
Qualification (PQ)], and Hazard Analysis
• Work Instructions (WI)
• Job Aids
• Guidelines
• Test Cases (Test Scripts)
• Training Materials
• Matrices (Matrix)
• Forms
Management Systems / Regulatory Experience:
Prepared documents based on quality and regulatory requirements related to the following
management systems and regulations:
• ISO 9000, Quality Management System
• ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
• ISO 14000, Environmental Quality Management System
• ISO 14971, Medical Devices – Application of risk management to medical devices
• ISO 20000, Information technology – Service management
• ISO 26514, Systems and software engineering – Requirements for designers and developers of user
documentation
• ISO 27001 - Information technology -Security techniques -Information security management systems -
Requirements
• ICH Q7a, Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API)
• 21 CFR Part 11, : Electronic Records; Electronic Signatures
• 21 CFR Part 210 and 21 CFR Part 211 - Drug CGMP Regulations
• 21 CFR Part 820 Quality System Regulation (QSR)
• 29 CFR Part 1910, Occupational Safety And Health Standards (OSHA) [Process Safety Mgmt. (PSM)]
EXPERIENCE
Bristol-Myers Squibb (BMS), Plainsboro, New Jersey, 10/2013 – 12/2013
Contract Technical Writing Consultant, Biopharmaceutical Drug Manufacture, Sales, and
Distribution
Facilitate knowledge transfer for the new North America Capability Center (NACC) for knowledge
workers in Global Travel & Meetings Operations, Freight Payments & Reporting, and IT Audit
Response. Activities included SOP, WI, Process Flows, and Job Aid document research, retrieval,
staff interviews, preparation, and organization (Approximately 100 documents).
Terumo Medical Corporation, Somerset, New Jersey, 01/2013 – 03/2013
Contract Technical Writing/Validation Consultant, Medical Device Manufacture, Sales, and
Distribution
Facilitate JD Edwards financial software upgrade validation for two facilities with multiple financial
and technical departments (Accounts Payable, Accounts Receivable, Treasury, Financial Close,Fixed Assets / Standard. Costing, Inventory, Order to Cash, Plan to Manufacture, (Includes
MRP/DRP), Plant Maintenance, Procurement to Pay, and Technical Considerations). Perform data
gathering and document preparation for User Requirements, Functional Specifications, Hazard
Analyses, User Testing Protocols, and Test Scripts.
J&J Healthcare, Piscataway, New Jersey, 10/2012 to 01/2013
Contract Technical Writer, Medical Device & Diagnostics Sales and Distribution
Prepare and revise technical Standard Operating Procedures (SOP), Work Instructions (WI), and a
Process Narrative (PN) to support the standardization of documents for the Information Technology
Division (IT). The SOPs present information, including process maps, on how to operate and
maintain IT applications/processes. The Work instructions present application-specific and process-
specific details based on the related SOPs. The PN presents a high-level description of IT
operations. Detailed subjects include: 1) documentation related to systems administration standards;
2) change control standards and procedures for business applications and network platforms; 3)
standards and procedures related to information systems security; 4) data management standards;
and 5) software deployment and administration standards and procedures. The revisions include
conversion of legacy documentation (SOPs and Work Instructions) to a form that is consistent with
current documentation. Develop new information systems procedures to address current business
approach. Consult with IT managers, applications developers, and systems administrators to gain a
full understanding of the technical business operations and requirements that are subject to document
development.
GE Healthcare (Omnyx), Piscataway, New Jersey, 03/2009 to 03/2011
Contract Technical Writer, Medical Device Design / Manufacture
Author/editor for about 100 Quality Design Control, Information Technology (IT), and Production
documents. Documented processes for electronic document and product data management
applications. Prepared documentation related to Electronic Records and Electronic Signature
controls, Requirements Specification, Risk Assessment, and Disaster Recovery. Created the process
management spreadsheets for, and participated as team member, reorganizing the document
management system. Tested application functions. Performed administrative tasks for a SharePoint-
based electronic document and quality management application. Performed document management
tasks; including distribution for review and approval, and follow-up to expedite reviewer/approver
electronic signature. Performed document gap analysis to meet Quality System Requirements.
Created and maintained document lists for reference and progress analysis. Assembled and
maintained the Quality Training Files.
Bristol-Myers Squibb (BMS), New Brunswick, New Jersey, 06/2007 – 06/2008
Contract Technical Writing Consultant – Drug Manufacture
Prepare Work Instructions (WI) for Drug Development equipment and processes, in a recipe-driven
Batch Process environment, for out-of-recipe and manual operations during setup, processing, and
cleaning. Harmonize WIs across different Drug Development areas to minimize cross training and
minimize duplication of instructions. Edit existing WIs to meet new Procedural Document SOP.
Prepare documents using a new Knowledgebase Document Preparation System (ExpressTrain).
3M Corporation, Belle Mead, New Jersey, 05/2006 - 08/2006
Contract Technical Writer – Construction Materials Manufacture
Prepared documentation for ISO 14000 Certification Project, including SOPs and Work Instructions
for the Waste Storage, and Management Systems
Sanofi-aventis Pharmaceuticals, Bridgewater, New Jersey, 04/2004 - 12/2004
Contract Technical Writer – Drug Manufacture
Worked on the Cognos Software Consolidation Project, developed the Training Program, and
prepared the Logical Security SOP.
Contract Lead Technical Writer
Data Center Convergence Project and Data Center Qualification (Validation of software controlled
systems) of Architecture, Infrastructure, Physical Security, Data Center Environment, Power
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Distribution System, Equipment Receiving and Shipping, Server/Telecom Equipment Cabinets,
Network Equipment Preparation and Installation, Network Cabling and Support Structures, and
Backup and Storage Software and Hardware
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Thomas J. Flahive
PharmITnow, Plainsboro, New Jersey, 06/2003 – 04/2004
Trainer - Microsoft Office Applications
Trainer in a classroom situation, for Microsoft Office applications (Word, Excel, Access, and
PowerPoint)
Taratec Development Corporation, Bridgewater, New Jersey, 10/2002 – 06/2003
Staff Consultant – FDA and International Standards, Contract Projects
Software Validation Analyst - Merck, Rahway, NJ -
Software Validation PQ Coordinator - Forest Laboratories, Jersey City, NJ
LIMS Infrastructure Analyst - Baxter Laboratories, New Providence, NJ
Audit Report Technical Writer - Janssen Pharmaceuticals (J&J) Titusville, NJ
Taratec Internal Projects
Taratec Employee Handbook, SOPs, Quality Documentation Team Member, Sales & Marketing,
assisted in improving the writing skills of consultants.
Ingenix, Basking Ridge, New Jersey, 05/2002 - 08/2002
Contract Software Validation / Documentation Specialist – FDA and International Standards
Contract Research Organization (CRO) - Oracle Clinical and Imaging software upgrade, validation,
system support and training and maintenance. Data Management System Requirements
Specification for Case Report Forms (CRF) and Data Clarification Forms (DCF).
Perot Systems, (The Robert Plan Account), Edison, New Jersey, 06/2000 – 01/2002
Staff Technical Writing Specialist/Senior Technical Writer – Insurance
Insurance company – Prepared a variety of System Management documents including, the 2002
Information Technology (IT) strategic plan, Disaster Recovery, and Change Management
documentation. Authored SOPs and WIs for system processes, including more than 200 documents
for Management, Software Development Group, Help Desk Department, Management Information
Services (MIS), Security, Telecommunications, Technical Writing Department, and Production
(Operations Department, Underwriting, and Claims). Coordinated Change Management, Production
Control, and Problem Management meetings. Coordinated training conferences. Supervised and
mentored technical writers.
Johnson and Johnson, PRI, Raritan, New Jersey, 11/1998 – 01/1999
Contract Business Consultant – Drug Manufacture
Y2K compliance issues in facility management, manufacturing and laboratory equipment and
instruments.
Johnson and Johnson, Ortho McNeil, Raritan, New Jersey, 10/1998
Contract Environmental Auditor – Drug Manufacture
Environmental aspects of facility and manufacturing equipment, and laboratory instruments
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EDUCATION
Rutgers University, New Brunswick, New Jersey; B.A., Geology, 1979
Target Training, Kenilworth, New Jersey; Computer Repair and Configuration
NJIT, ISACA, Information Systems Audit Training
ADDITIONAL TRAINING
HP Quality Center (HPQC)
Systems Development Life Cycle (SDLC)
SharePoint Training
GMP Training
ICH Q7a Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Training
Certified Miner Training
Certified Information Systems Auditor (CISA) Training
GxP Training
Computer Systems Validation
21 CFR Part 11 (SOX), Awareness Training
Validating Configurable Commercial Off-The-Shelf (COTS) Applications
ISO 9000 Lead Assessor Training
TECHNOLOGY
Adobe PhotoShop, CompliantPro, DocCompliance, Doc-To-Help, ExpressTrain, FrontPage, HomeSite,
HPQC, HTML, Microsoft Office Suite, Multi-Tier and Cloud Operations, NextDocs, Remedy, ServiceNow,
SharePoint, SnagIt, Visio
PUBLICATIONS AND PRESENTATIONS
The ISO 14000 Miniguide, Quality Resources
ISO 14000- What to look for when Auditing - ASQ
INTRODUCTION TO ISO 14000 - Connecticut Quality Council
CAN QUALITY PROFESSIONALS TACKLE THE ENVIRONMENT? – ASQ
PROFESSIONAL ORGANIZATIONS
Society for Technical Communication (STC)
International Organization for Standardization (ISO)
American Society for Quality (ASQ)
International Webmasters Association (IWA)
HTML Writers Guild (HWG)
CERTIFICATIONS
Certified Miner, June 2006
Certified Quality Auditor (CQA), 1993 - 2003
Certified Professional Geologist (CPG), Since 1994
MILITARY SERVICE
U.S. Air Force - Sergeant
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