PROFESSIONAL PROFILE:

• 20+ years as a technical writer/editor and documentation specialist, working with subject matter experts to produce and edit security documentation, CSV documentation, online help, process documentation, work instructions, slide presentations, trade show presentations, RFP’s and RFQ’s.
• Several years of experience in the Pharma Industry and Medical Device Industry creating SDLC, QA and FDA/GXP compliance documentation. Competent in Visio for architecture diagrams and process flow diagrams.

TECHNICAL SKILLS:

Word, PowerPoint, Excel, Visio, FrameMaker, Photoshop, Acrobat, SnagIt, Lotus Notes, WebWorks, RoboHelp, Star UML, Documentum, SharePoint and code repository systems like ClearCase and SourceSafe

PROFESSIONAL EXPERIENCE:

Confidential, McHenry, IL

Technical Writer / Editor

Responsibilities:

• Produced Security Risk Assessment related to a new medical device product line
• Updated network security standards
• Updated cryptographic and key documentation

Confidential, Sacramento

Technical Writer / Editor

Responsibilities:

• Worked on a short term contract to update security architecture documents related to California Medicaid systems
• Updated requirement documents
• Used SharePoint, Word, Visio and Agile methodology

Confidential, Sacramento

Technical Writer

Responsibilities:

• Updated detailed design documents related to California Dept. of Corrections healthcare system
• Gathered information from SME’s such as computer system architects, developers and field engineers
• Updated infrastructure diagrams and requirement documents
• Used SharePoint, Word, and Visio

Confidential, Iowa City, IA

Technical Writer / Editor

Responsibilities:

• Reported to the Technical Project Manager in business operations
• Used Agile methodology while working with IT developers and business users to produce functional design specifications
• Reviewed and updated process flow documentation for Confidential ’s online CBT (computer based testing) for college entrance
• Used SharePoint, Word, Excel and Visio to produce Functional Requirements, Test Plan and User Guide for the front end of an Access database

Confidential, Little Rock

Technical Writer / Editor

Responsibilities:

• Reported to the QA Manager and created SDLC documentation related to the Affordable Care Confidential
• Produced system documentation about IBM WebSphere deployments and integration of web applications
• Reviewed and updated Security Plan, Internet Security Design and Information Security Risk Assessment
• Used Agile methodology and SOA with tools such as Word, Excel, SharePoint and PowerPoint

Confidential, Folsom, CA

Technical Writer / Editor

Responsibilities:

• Reported to the lead architect for the Medfield, Merrifield and Clover Trail platforms and worked with all developers in those projects
• Edited and updated Firmware Architecture Specifications (FAS) for Intel’s Atom chip sets in smart phones and other mobile devices.
• Reviewed and updated APIs and SDKs.
• The PDF documentation described the boot flow process, which included encryption and internet security details.
• Used conditional text for an audience of internal engineers and a less sensitive version for an audience of customers.
• Used FrameMaker, Acrobat Pro, Visio and Word

Confidential, Reading, PA

Technical Writer

Responsibilities:

• Documented Medical Device Verification and Validation of a new Radial Artery Access Kit for cardiac catheter diagnostic procedures
• Tools used were SharePoint, Agile CM, Word, Excel and Nikon Digital Camera
• Edited and updated SOPs related to production runs and work station batch records
• Created a V&V Plan, Risk Assesment, IQ Protocol and work instructions for new trim station process
• Coordinated technology transfer with QA and production engineers in Juventud, Mexico

Confidential, Omaha, NE

Technical Writer

Responsibilities:

• Created RFP (Request for Proposal) for a securities management system
• Gathered business requirements and documented the conversion of a portfolio management system from a legacy mainframe platform to an enterprise architecture, JAVA Web - based Cloud platform
• Created a business requirements document for a securities (investment) management system
• Gathered business requirements for a cash management system and wrote an install procedure that integrates the system with SAP.
• Created UML context diagrams, use-case diagrams, design diagrams and sequence diagrams in an Agile/SOA/Cloud/Web-based environment. Used SharePoint, Visio and Star UML

Confidential, Philadelphia, PA

Audit Report Editor

Responsibilities:

• Worked on an audit team that inspected Abbott Diagnostic Division (ADD) in Texas, Illinois, California and Ontario.
• One focus of the audit was Medical Device Reports (MDRs) that should be filed promptly with the FDA. Another focus was security of patient information.
• Edited and formatted daily, weekly and final audit reports
• Tools used were Word, Excel, Visio and PowerPoint

Confidential, Deerfield, IL

Technical Writer

Responsibilities:

• Produced system architecture and flow diagrams in Visio.
• Worked in an FDA / GXP regulated environment to create computer system documents in Word that summarized security plans, business objectives, process flow, server interaction, roles and responsibilities, operations, issues and limitations

Confidential, San Jose, CA

Technical Writer

Responsibilities:

• Produced Computer System Validation (CSV) documentation, including validation and development Standard Operating Procedures (SOP’s). Used Word, Visio, SharePoint and InfoPath, which is effective for creating interactive risk analysis templates
• Organized meetings with IT managers to edit policy documents, development procedures and a DRP
• Created templates in Word for validation documents, such as FURS, System Design, Test Plans, Test Cases and Summary Reports. Performed tests on statistical analysis software
• Produced forms for a system inventory and assessing regulatory risk (21 CFR Part 11 and Sarbanes-Oxley SOX ).

Confidential, Warrenville, IL

Technical Writer

Responsibilities:

• Gathered business requirements, produced System Administrator documentation and user documentation for a laptop based simulator that evaluates brokers and traders who work in energy markets.
• The system trained traders to hedge their positions with swaps and futures and decrease exposure by reduced buying in falling markets

Confidential, Coudersport, PA

Technical Writer

Responsibilities:

• Gathered information from subject matter experts to create server run books and a disaster recovery plan detailing Confidential ’s UNIX based billing and customer service systems for cable modem operations, which run Oracle and Remedy

Confidential, Kankakee, IL

Technical Writer

Responsibilities:

• Worked with SMEs to produce a Summary Report that validated newly developed pharmaceutical workflow software running on a mainframe system. This report traced several hundred requirements and specifications related to production line functions through all of the system development life cycle (SDLC): requirements, design, coding, unit testing, integration testing, installation qualification, operational qualification and production qualification
• Edited and updated all changes, such as adding, deleting and modifying specs. The report detailed every test objective and acceptance criteria, noting test passes, failures and corrective action
• The Report described each spec as it ended up in the production system, so that each spec could be traced back via Traceability Matrix through the Summary Report to Design and Requirements
• Created SOPs related to production runs and work station batch records
• Wrote an SOP for reviewing software tests. Reviewed tests. Wrote test scripts. Performed tests, including specs for 21 CFR Part 11
• Tools used were Documentum, Word, and Oracle