Specialization:8 years of consulting experience in documentation, operational support, business process and training material design, validated system development, and training of document management application software.

• Hardware: IBM PC, Macintosh Apple, Xerox Laser Printers
• Database: SYBASE, MS SQL, Oracle Operating Systems: MAC OS, Windows 3.X, 9.X, 2000, NT , MS-DOS
• Software: Lectora, Viewlet Builder, Test Director, Impact, Saba Rapid Learn LMS , MS Publisher, MS FrontPage, MS Word, WordPerfect, Adobe Photoshop, Siebel Reporting, Visual SourceSafe, MS PowerPoint, MS Excel, ABC Flowcharter, MS Visio, Peoplesoft Vantive , Clientele, Norton PC Anywhere, XML Epic , All Clear, MS Outlook, GroupWise, Lotus Notes, Documentum, FDGMP First Docs for Good Manufacturing Practices , NetMeeting, SnagIt, MS Paint, Caper, Telelogic DOORS, GdocS Configured system that is a combination of FDGMP, Documentum, Adobe, and Epic XML Editor , Adobe Acrobat, Internet Explorer, Sharepoint, Visual SourceSafe, Netscape Navigator, Crystal Reports, Remedy, and Powerway Document Management Quality Control software including: Audit Manager, Corrective Action, Quality Planner, SPC, Procedure Writer, Instruction Writer, Policy Writer, and Document Manager.

Experience:

• Technical Writer/Validation Engineer: Medpace 05/2006-08/2006 As a Technical Writer/Validation Engineer for a Clinical Research Organization my duties included:
• Interface with developers and business SME's to gather system information/usage, functionality, and business processes to complete requirements in order to comply with FDA computer system validation guidelines. Create and maintain system documentation for system validation packages following the SDLC and other in-house procedures Requirements, Test Plan, design documents, training documentation, etc Create and maintain system training materials Document Management of validation documentation Version control, hard copy signature retention, filing hierarchy, etc Business Analyst/ Technical Writer:CHC, assignment at Procter Gamble 12/04-05/06
• As a Business Analyst/Technical writer on a Clinical Trial Management System CTMS project my duties included: Developing interactive computer/web-based training materials Developing training manuals, and other job-aids Develop and maintain web pages Design of system logos, promotional materials, burning CD's for training, basic marketing, etc. Business process definition and mapping Web publishing for training materials and processes Part of sub-project to identify and define requirements for and choose a learning management system. LMS . Documented requirements, presented different system options, and participated in the rollout and administration of the selected LMS. Formal/informal system testing System design input via interfacing with end users and core team members that acted as SME's. Teamspace management via Lotus Notes Creating, revising, and reviewing documentation for the project. Admin manuals, training forms, training materials, test scripts, system security documents, etc Providing documentation and consulting support for core and extended team members during design/implementation of the CTMS. Management of project files on network server, drafting mass email messages, scheduling conference calls and web casts, taking minutes for board/team meetings, scheduling meetings/booking rooms, etc
• Assist with testing of interfaces and standard reports Preparation of test scripts for OQ and user acceptance. Business Analyst/ Technical Writer: Analysts International, assignment at Eli Lilly and Company 9/01-12/04
• As a Business Analyst/Technical writer my duties included: Creating, revising, or formally reviewing documentation for the project including: Computer System Validation documents, surveys to customers, design documents, business process flowcharts and narrative, security matrix for users, site implementation documentation, research compilation from customer examples/business needs, training materials, and testing related documentation requirements, test cases, test scripts, and trouble tickets . Evaluation of and training on the vendor's off-the-shelf application in order to define gaps between available functionality and business requirements that should be integrated into the system design. Interface with product developers to ensure client requirements are translated to system enhancements and configuration parameters
• Interview business SME's or site sponsors in order to gather information for system functionality and then translate the business need into functional requirements. System testing/Client Acceptance: Reviewing and revising the requirements specification, creating and reviewing test cases, and writing and execution of test scripts. Training over 20 business end users and project members on system functionality and business processes. Coordinating and participating in weekly implementation meetings with US and European sites. Providing documentation and consulting support for core business team members during design/implementation of a global document management system called GdocS. Drafting mass email messages, scheduling conference calls and web casts, taking minutes for Global teleconferences, scheduling meetings, etc Technical Writer/Technical Support Analyst: Powerway Inc. 5/98-9/01 As a Technical Writer/Technical Support Analyst for a software development firm my duties included: Conducted individualized document creation and quality consulting for various customers on-site. Visited customer locations and constructed customized templates, deployed the document control system, provided advice and consultation on how to handle quality issues in regards to the standards, and authored documentation. Collaborated with the performance improvement coach for technical services knowledge and solutions support to create and improve E-Learning courses dealing with the Powerway.com product. Served as the Technical Services representative to review, test, and ensure that courses met training objectives, and that the modules worked correctly throughout the various product development cycles. Trained over 15 new technical analysts to use the call tracking software, solving customer issues, using Powerway software, providing existing company documentation to carry out departmental duties, and using soft skills to ensure proper call handling and customer satisfaction. Interpreting and documenting customers' needs and relaying them to the product development team for future fixes and release of multiple software application.
• Conducted training for over 50 new employees on the corporate document control software. Updated training guides to address the needs of the company and assisted Human Resources representatives to incorporate updated and departmental-specific materials. Participated in various testing scenarios and defect testing in the software quality assurance department for more than two major upgrades to the Powerway software on over ten different personal and server/client operating system environments. Fielded inbound calls/emails that dealt with the Internet product from all new customers and trained employees as a member of the new Powerway.com support team. Supplied tier one phone support to a broad customer base, mainly in the US but additionally from other countries as needed. Support included: application of the software, installation/deletion of the software, printing problems, network problems, troubleshooting of various error messages, upgrades, system configurations, basic navigation of our software on WINDOWS 3.x and higher, and general troubleshooting. Furnished follow up support, seeing the customer through to completion. Worked well with the team environment in the Technical Services Department, as well as with Customer Service, Sales, and Development. Provided support for operating systems from WINDOWS 3.x and higher, NOVELL, NT networks, SYBASE, MS SQL, and ORACLE database types and CITRIX. Served as the primary Call Coordinator backup responsible for fielding and logging all incoming customer help desk calls to ensure proper customer service, database administration, verification of service agreements, and proper callback times. Application Clerk: Columbia House 5/95-2/98

As an Application Clerk for a mail-order company, responsible for coding customer applications and ensuring the order is processed correctly. Performed batch balances for the pre-paid accounts.