SUMMARY:

Versatile project leader and expert writer for technical projects at major corporations and small companies. Effective as a sole writer, as well as a team member. Successful documentation manager/writer, project leader/writer, and independent consultant. Writing and technical experience in: cGMP and 21 CFR Part 11

AREAS OF EXPERTISE:

Quality Management DB Systems

Asset Management Systems

Document Control Systems

Networking Applications

Web Applications

Agile Development

Business Applications

Usability Analysis

SOFTWARE EXPOSURE:

Content Development: Madcap Flare, xMetal, DITA, SDL LiveContent, Visual Studio, VMware, WebWorks (JavahelpWebHelp, and AutoMap), RoboHelp Office, FrameMaker, ePublisher, Adobe Acrobat and IllustratorVisio, PDF, XML, Dreamweaver, Camtasia, ScreenCam, Microsoft Word and PowerPoint, SharePointPaintShop, Photoshop, Illustrator, HiJaak, SnagIt

Source Control: CVS, WebCVS, VSS, SourceOffSite

Manufacturing: Attache, InforEAM, TrackWise, RQM, PDM Windchill, LiveLink

PROFESSIONAL EXPERIENCE:

Senior Technical Writer

Confidential, Worcester, MA

Responsibilities:

• Working with Confidential Engineering, Operations, and Quality Assurance Groups, created new Standard Operating Procedures (SOP) for a state - of-the-art cell culture manufacturing suite.
• Procedure development required in-depth focus, specifically on SUB-to-SUB Transfer, Transfer Panel, and Harvest Tank operations.
• Created Visio diagrams to represent the operation tasks.

Confidential, Milford, MA

Responsibilities:

• Primarily responsible for the Confidential and Confidential Database Manager documentation.
• Confidential is produced in an Agile development environment and localized into eight languages.
• The documentation tools are Madcap Flare and Visual Source Safe.
• Also used VMware, DITA, xMetal, and SDL LiveContent for other projects.
• Received the group’s Best New Idea award for a concept to present introductory material in video format.

Confidential, Allston, MA

Responsibilities:

• Provided documentation support for a major facility renovation project including new, state-of-the-art equipment, systems, and areas for the upstream manufacturing of Confidential ® at the Confidential .
• Also, supported the first implementation of an electronic preventive maintenance system at Confidential, using the InforEAM asset management system.
• Documentation included job plans, existing maintenance reviews, and standard operating procedures.

Confidential, Marlborough, MA

Responsibilities:

• Supported validation documentation activities during the migration of the Confidential SAP R/3 environment from Sun to IBM systems.
• Also, supported validation activities during the upgrade from SAP R/3 to SAP ECC 6 for servers and over 100 interfacing applications.
• Documentation included requirements, system design, risk analysis, trace matrices, system integration, specified and executed test plans, installation qualifications, etc.

Confidential, Allston, MA

Responsibilities:

• Coordinated review and approval with internal stakeholders and routed the documents through Confidential ’s document control system resulting in successful external verification.
• Assisted with compilation of the trace matrix, document concurrence, and other project documents.

Confidential, Natick, MA

Responsibilities:

• Wrote design, configuration, installation, and procedure documentation for Confidential ’s Global Complaint System.
• Confidential tracks and files product complaints with the FDA automatically. It is an implementation of the TrackWise quality management application based on an Oracle/SQL database.
• Responsible for the 2100-entry Master Trace document for Confidential .
• Edited test plan and result documents and was responsible for routing through a Windchill document control system.

Senior Technical Writer

Confidential, Cambridge, MA

Responsibilities:

• Wrote online help and developer knowledgebase articles in HTML using Dreamweaver for PegaRULES Process Commander, a rules-based development application for the Business Process Management industry. PRPC enables developers to generate Java business applications using a reusable set of hierarchical rules.

Confidential, Cambridge, MA

Responsibilities:

• Created custom format in a graphic style and wrote corporate policies and procedures for troubleshooting content streaming services.
• Established network troubleshooting policies and procedures for WMS, Real, QuickTime, and Flash on-demand and live streaming services.
• Conducted procedure usability testing with service engineers.
• Wrote API documentation for the Global Network Visualization product, GNET and the U.S. DoD GCDS Portal.

Confidential, Marlborough, MA

Responsibilities:

• Coordinated documentation rebranding process for VCX VOIP products with Confidential OEM partners and technical writing vendors.
• Documentation covered convergence IP telephony, media gateways, IP conferencing, and IP call center products.

Information Development Project Leader/Lead Writer

Confidential, Burlington, MA

Responsibilities:

• Created and implemented a design for online help that became a group standard. Developed the 800-file help system using a custom template of WebWorks Javahelp. Provided usability feedback. Implemented WebWorks AutoMap.
• Created organization and implemented a 500 page, five book documentation set. Created source files using FrameMaker and produced both PDF and Javahelp output from the single source files.
• Led a virtual team of 3 to 7 people (writers, editor, and graphic artist) to produce the documentation set and help system. Remote team members located in Mountain View, Boston, Helsinki, and Hyderabad, India.
• Maintained project schedule and staffing in Microsoft Project. Maintained project documents on an intranet site.
• Represented Information Development on Program Management Team. Coordinated with program management, development, quality assurance, marketing, and systems engineering.

Documentation Manager/Principal Technical Writer

Confidential, Marlboro, MA

Responsibilities:

• Developed and managed program for Digital’s system performance information delivery.
• Created Digital's Performance Summary publications for characterization of new system performance in specific application areas and configurations.
• Managed teams of two to four writers focused on documentation of workload software products in both VMS and UNIX application environments.