HASBROUCK HEIGHTS, NJ 07640
TECHNICAL WRITER with over ten years of Document Management/Quality Systems experience supporting mostly pharmaceutical clients such as Johnson & Johnson, Schering-Plough, Stryker Orthopaedics and Merck.
●Strong experience in IT infrastructure Architecture, Configuration Management and Data Center/Disaster Recovery operations.
●Strong applications-support background in enterprise software environments and extensive experience supporting and implementing FDA-regulated document management systems.
●Experienced in documenting business requirements, use of diagrams and flowcharts, developing and executing test plans and test cases to support new releases.
●Microsoft Suite (Word, Excel, PowerPoint, SharePoint)
●Content/Document Management Applications: SharePoint, Documentum, eRoom, EDMS, Windchill.
●Document Publishing Applications: FrameMaker, Adobe Acrobat Professional, Adobe LiveCycle Designer.
TOURO COLLEGE OF DENTAL MEDICINE – at New York Medical College
●Edited and revised 400-page policy manual for dental students.
●Worked with Dean of students to streamline school processes and policies for new policy guide.
MERCK Research Laboratories, Clinical Systems - SDLC Technical Writer/Requirements Gatherer. (5/12 to 8/12)/ (7/13 to 10/13)
●Created SDLC documentation for a Documentum-based document management system migration and enhancement project.
●Worked with technical teams to collect requirements and publish SDLC documents.
●Worked with quality team to ensure end products met the requirements for the new Merck
JOHNSON & JOHNSON, - Information Technology Services (ITS) - Business Intelligence - Business Analyst/Technical Writer.
(09/2012 to 04/2013)
●Responsible for Cognos TM1/Teradata release documentation including:
●Service Guides and Manuals
●New Project Questionnaires, SOP’s, and Work Instructions
●Created IQ, OQ, PQ’s for and other operations-related documentation.
●Mid-Point Project Documentation Audit 2/15/2013 resulted in zero observations.
JOHNSON & JOHNSON, Information Technology Services (ITS) - Disaster Recovery Operations - Technical Writer.
(01/2012 to 05/2012)
●Gathered new global Data Center/Disaster Recovery requirements and drafted and authored new documentation (master strategy and network, storage and facilities guidelines) to support new strategy.
●Reviewed initial drafts of all documentation with authors and made recommendations.
●Participated in high-level group sessions to discuss documentation parameters
●Worked with external consultants contracted to assist in the project and managed all project-related documentation.
JOHNSON & JOHNSON, Information Technology Services (ITS), Configuration Management - Technical Writer.
(09/2011 to 01/2012)
●Gathered requirements and authored SDLC documentation (functional specifications, user requirements, design specifications, Traceability Matrices, etc.) for a new global asset management database – Service Now (CMDB).
●Closeout Project Documentation Audit 01/15/2012 resulted in zero observations/ 2 recommendations.
●Revised information from existing process definition documentation and created new SOP and Work Instruction document drafts.
●Reviewed initial drafts with teams, jointly determining how to fill gaps.
●Participated in the review of the documents with Q&C.
●Identified, contacted and worked with owners of SOPs and WIs that needed modifications to support Service Now Release 1.
●Submitted new and/or updated documents into EDMS and actively participated in the review and approval process.
SANOFI-AVENTIS, Global Information Systems - SharePoint 2010 Applications Support.
(04/2011 to 07/2011)
As part of the SharePoint 2010 global rollout, worked to support the application development team providing technical and functional support, which included:
●Designing and developing beta training documentation site using web parts
●Working with developers to identify gaps, needs and known issues in third-party proprietary web-parts.
●Creating online video tutorials (Adobe Captivate) as training to support the Workspace.
KPMG, LLP, Advisory Services - SharePoint Training Applications Support.
(08/2009 to 01/2011)
●Developed detailed user requirement documents
●Provided detailed functional design specifications for technical teams that included use-case documents, diagrams, screen mockups and wireframes
●Developed and executed test plans and test cases to support new release
●Worked with programmers and analysts to create end-user training materials.
●Created FAQs, Quick Reference Cards, User and Administrator manuals and Risk Management-related SOPs.
JOHNSON & JOHNSON, Ortho Biotech - Clinical Affairs - Process Analyst.
(11/08 to 8/09)
●Created process SOPs based on Clinical Affairs workflows
●Analyzed Clinical Applications and Systems and prepared Requirements Documentation
●Created Clinical Systems checklists, work instructions, IQ, OQ, PQs, SOPs, and other IT related documentation used in database installations, upgrades, and patches.
●Prepared test logs and test scripts per Sarbanes-Oxley requirements.
●Created Clinical Systems Training Guides for end-users
STRYKER ORTHOPAEDICS, Quality Systems – Technical Writer/Systems Administrator.
(9/04 to 11/08)
●Worked with Quality Systems Documentation group to create, edit and publish companywide standard operating procedures and technical documents.
●Conducted internal audits of manufacturing and R&D areas for quality and environmental issues and issued reports to top management.
●Created training materials to support new releases/rollouts.
SCHERING-PLOUGH CORPORATION, Global Quality - SOP Writer/Technical Writer.
(09/01 to 09/04)
●As part of the consent decree, worked with senior-level management team in rolling out and implementing Quality Standards to 16 FDA-Regulated sites through Documentum document management system.
●BA, Communications 1994; Ramapo College of New Jersey
●MBA, Communications 2004; Fairleigh Dickinson University
References and Samples available.