SUMMARY:

Wrote User Guides, GUI Procedures and Standard Operating Procedures (SOPs) for Confidential . While at Confidential, located in Lowell, MA, wrote User Guides, Release Notes, Specifications and other supporting documentation utilizing Good Clinical Practices (GCPs) for the Alere Clinical Surveillance Product Suite. Quickly documented the application from the Alere portal while working with Development to create newly written manuals and update new features. Provided Confidential Pharmaceuticals in Framingham, MA with newly written SOPs required for the production of Fabrazyme, a highly regulated and meticulously documented (FDA, GMP) production facility. While at Confidential Corporation (acquired by Confidential Healthcare), wrote, edited and produced Operator Manuals, Service Manuals, Work Instructions (WI), SOPs, and Information for Use (IFU) documentation, Test Procedures, Marketing Brochures, Failure Mode Effects Analysis (FMEA) and a variety of other documentation. Confidential develops and manufactures guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease.

TECHNICAL SKILLS:

• Microsoft PowerPoint
• Microsoft Excel
• Microsoft Visio
• WinZip
• SnagIt Screen Capture
• Information Mapping
• HTML
• Content Management
• Adobe FrameMaker
• PDF
• Clinical Surveillance Data Interface Specification - Version 1.2H
• System Manuals
• Operator Manuals
• User Guides
• Administrator Guides
• Release Notes
• GUI Documentation
• Programmer Guides
• Information for Use (IFU)
• PowerPoint: Graphics
• Marketing Brochures/PowerPoint Presentations
• Work Instructions (WI)
• Standard Operating Procedures (SOPs)
• Good Clinical Practices (GCPs)
• Good Manufacturing Practices (GMPs)
• Piping and Instrumentation Diagrams (P&IDs)
• Agile database
• Oracle (HTML)
• IBM (HR Access)
• Teamcenter Product Lifecycle Management (PLM)
• Microsoft SourceSafe

EXPERIENCE:

Confidential, Lawrence, MA

Sr. Technical Writer

Responsibilities:

• Wrote new procedures via the Porthos software portal including screen caption generation.
• Updated existing Standard Operating Procedures (SOPs) using Microsoft Office.
• Designed and updated a Welcome Packet for new employees.
• Prepared Instructional Design-based material to be used to train internal employees as well as the Wireless customer base.

Confidential, Lowell, MA

Sr. Technical Writer

Responsibilities:

• Worked with Alere Software Development and Business Analysts to write User Guides, Release Notes, and Technical Specifications to support the Confidential Clinical Surveillance Product Suite including:
• The Medication Management Module for Administrators User Guide and Release Notes
• The Infection Control Module User Guide and Release Notes
• The Population Health Management User Guide and Release Notes
• Used the Confidential Style Guide and templates to ensure a consistent, professional, look and feel.
• Using the software portals, gained the product knowledge to document in-depth navigational paths through the Graphical User Interface for each product.
• Wrote Operating Procedures and defined product functionality.
• Captured screens using the Snag-It screen capture tool.
• Created new graphics using Microsoft Visio.
• Responsible for archiving both Microsoft Word and pdf documents on the Alere master drives.

Confidential, Framingham, MA

Sr. Technical Writer/Training Specialist

Responsibilities:

• Received all on-line and instructor training required by the FDA to write documentation for Confidential .
• Wrote Standard Operating Procedures (SOPs) from engineering documentation, Piping and Instrumentation Diagrams (P&IDs) and reference materials.
• Applied extensive experience in researching and organizing the operational bases of complex and highly specialized equipment.
• Prepared information in the precise methods required for the production of pharmaceuticals in a highly regulated and meticulously documented (FDA, cGMP, et al) production facility.

Confidential, Billerica, MA

Sr. Technical Writer

Responsibilities:

• Wrote documentation for several divisions located within Confidential Corporation including Research and Development, Engineering Services, and Marketing Communications.
• Wrote Information for Use (IFU) documentation, Systems Manuals, Engineering Support Manuals, Marketing brochures and presentations.
• Supported Software Development: migrating software requirement documentation from Microsoft Word format to the Teamcenter Product Lifecycle Management (PLM) database.
• Wrote/updated several Service Manuals and Operators Manuals to support Engineering Services that include Test Procedures, Work Instructions (WI), Troubleshooting, and Software and Hardware Specifications.

Confidential, Newton, MA

Sr. Technical Writer

Responsibilities:

• Obtained all source material from Engineering documents, Design Specifications and drawing packages.
• Created new template, style guide and format.
• Generated cleanly edited, cropped professional photographs and artwork.
• Created Adobe .pdf files for Executive Team review cycles.

Confidential, Andover, MA

Sr. Technical Writer

Responsibilities:

• Provided feedback to 500+ authors worldwide that included product knowledge, procedural writing, formatting, language, and publishing.
• Tracked writing progress and evaluations using Microsoft Excel spreadsheets. Reports were submitted weekly to the Program Manager.
• Learned the company product line quickly and was given a company computer setup for telecommuting.

Confidential, Shrewsbury, MA

Sr. Technical Writer

Responsibilities:

• Developed and wrote regulation compliance procedural documentation for medical device manufacturing.
• International Standards: ISO 9001 (ISO 1644-5) Quality Management Systems - Requirements for Regulatory Purposes, FDA 21 CFR 803, 812, 820, MDD 93/42/EEC, ISO 13485.
• Procedures and Work Instructions included Corrective and Preventive Action (CAPA), Quality Objectives, Quality Planning, Training, Identification and Traceability, Internal Audit Program, Supplier Survey, Customer Feedback and others. Applied Information Mapping to improve document efficacy.

Confidential, Framingham, MA

Sr. Technical Writer

Responsibilities:

• Implemented document design, format, and style.
• Validated and documented financial processes.
• Documented “how to” steps and navigational paths using SolArc Right Angle (SAR) software and the TopTech Terminal Authority system.
• Prepared for Bank Audits

Confidential, Everett, MA

Sr. Technical Writer

Responsibilities:

• Developed and wrote medical device manufacturing procedures from operator interviews and out-of-date Work Instructions.
• Prepared for FDA Audit.
• Implemented successful elements: Graphical Operator Interface format, process maps, boilerplate statements and consistent practice and engineering process changes.

Confidential, Nashua, NH

Technical Writer/Editor

Responsibilities:

• Wrote, modified, and enhanced new and existing User Guides, Maintenance Manuals, and Operating and Test Procedures using Microsoft Office, Adobe Acrobat, and PowerPoint authoring tools.
• Interviewed engineering staff and SMEs to gain product knowledge.
• Used screen captures, photographs, engineering drawings, and schematics to illustrate software display screens, hardware connections, and signals. Accurately described software interfaces.
• Managed schedules, prepared documentation status reports and prioritized projects to meet engineering and customer deadlines.

Confidential, Merrimack, NH

Technical Writer/Editor

Responsibilities:

• Wrote User Procedure Documents (UPDs) necessary to convert data from an Oracle (HRMS) database to an IBM (HR Access) database
• Communicated with Subject-Matter Experts (SMEs) and Business Analysts to ensure that process step documents, supplemental documents, and attachments were technically correct. Accurately described how to use the HR Access interface.
• Captured screen shots of various HR Access functionality using SnagIT and other graphics tools.
• Wrote supplemental documents and attachments used in tandem with process steps. Detailed procedures to complete the process, and are included as Reference Documents within each step as required.

Confidential, Lexington, MA

Reporting Specialist

Responsibilities:

• Complied with Lincoln Publications guidelines, templates and their LLDocs database.
• Worked from engineering notes and files, created a Technical Specification that supported a Signal Processing Motherboard (SPM) test plan and a Signal Processing Daughterboard (SPD) test plan.
• Converted files from Microsoft Word to Adobe FrameMaker, and delivered pdf’s for review.

Confidential, Boxborough, MA

Technical Writer

Responsibilities:

• Prepared documentation plans and managed schedules to support product deliverables.
• Tested and documented the hardware equipment and the software features through the Command Line Interface (CLI) and the Graphical User Interface (GUI) in an API environment.
• Wrote and produced the Confidential version (ONS 15216 OPM).
• Used Microsoft SourceSafe library to store Engineering and customer files.
• Created document templates used for customer projects.
• Converted files from Microsoft Word to documentation source files in FrameMaker. Engineering documents included the OWM Command Line Interface, the OWM GUI, OWM Boot Loader, OWM Spectrometer CLI and Spectrometer Boot CLI, OWR Command Line Interface, Device Descriptors, LC 485 Protocol, and Confidential final test specifications.
• Reported CLI and GUI errors to a program used for bug tracking.
• Resolved documentation bugs for the OWM and OWR User’s Guides.