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Technical Writers Resume Profile

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Summary

  • Writer with over 25 years of experience including 11 years as an FDA computer validation writer and validation analyst 21CFR Part 11 specialist for the pharmaceutical and medical device industry and an additional 15 years of experience as a combination writer/engineer for the telecommunications industry.
  • Writer of senior leadership speeches, broadband business unit communications, video scripts, press releases, executive correspondence, and executive biographies.
  • Experienced technical writer and editor of telecommunications, computer systems, digital systems, quality, sales and marketing documents, and business system documents and procedures.
  • Training Officer. Author. Quality Engineer. Telecommunications Engineer. Military Officer. Accountant. Webmaster.

SPECIALTIES

Corporate Customers: Abbott Labs, Eli Lilly, Siemens Medical Solutions, Quest Diagnostics, Amgen, Veteran's Administration, AT T, Motorola, Raytheon, Honeywell Analytics, State of Iowa, Raytheon, ISACA. Major Areas of Expertise: SDLC, Validation Documentation, 21 CFR Part 11, Telephone Switches, Telecommunications Infrastructure, Computer Infrastructure, Telephony, Pharmaceuticals, Computer Software Validation Analyst, CSV, Validation Engineer, Training, Knowledge Management Databases, Knowledgebase Server, ITSM IS Service Management , Biotech, Biopharmaceutical, Diagnostics, Document, Life Sciences, ITIL, Documentation.

COMPUTER SKILLS:

Hardware Experience

AT T UNIX 3B2 and 3B20 Computers AT T, Sun, and NCD Terminals IBM Compatibles PCs Macintoshes Scanners Zip Drives CD-ROM Writers.

Software Experience

  • Unix, Linux
  • Electronic Document Management System EDMS : Documentum, SourceSafe, Team Play, Sharepoint, Star Team, eDOCS, Primavera.
  • MS-DOS Products: Sharepoint, Windows, Windows NT, Windows 95, Windows 97, Windows 98, Windows 2000, Windows 2002, Windows XP, Windows 2003, Vista, Word 2007, Windows 7, Windows 8, Outlook, MS Word, MS Excel, MS PowerPoint, Visio.
  • Webmaster - HTML, Netscape, Internet Explorer, Foxfire, Dreamweaver, JAVA.
  • Validation, Test Tools, Databases Oracle, CaliberRM, ClearCase, Access, Team Track, Serena Mashups, Remedy.
  • Knowledgebase Servers
  • Other WordPerfect, Lotus 1-2-3, MS Office, Lotus Notes, Acrobat, Corel Draw, Snag IT, Citrix, Live Messaging, Same Time

Professional Experience

Confidential

Technical writer

Expert writer about computer infrastructure and telecommunications infrastructure both landline and wireless telephone switches .

Confidential

Technical writer

Wrote a series of process and procedure documents for a quality audit for an IT department.

Confidential

Technical writer

Automated the requirement management process for molecular imaging equipment using CaliberRm, a requirements management tool. Led the initiative to migrate requirements from Word documents on the Legacy platform to automated CaliberRM documents.

Confidential

Technical writer

Wrote System Design Documents SSD for virtualization infrastructure technologies, dynamic client computing strategies, and service oriented architecture. Subjects included dynamic operating system virtualization including presentation virtualization, application virtualization, OS operating system virtualization, disk virtualization, storage virtualization, Diskless PC Disk virtualization Diskless PC , Cloud computing, Big Data, as well as machine virtualization management tools.

Confidential

Technical writer/ Validation analyst CSV

  • Wrote Software Design Documents, User Requirement Specifications, Functional Requirement Specifications, Test Scripts, Use Cases, Trace Matrices and other 21 CFR Part 11 documents for the software document life cycle SDLC .
  • Wrote and performed software validation tests. Tested documents to determine their accuracy and completeness by performing user acceptance tests UAT .

Confidential

Technical writer

Wrote Software Design Documents, User Requirement Specifications, Functional Requirement Specifications, Test Scripts, Use Cases, Trace Matrices and other 21 CFR Part 11 documents for the software document life cycle SDLC .

Confidential

Technical writer

Wrote IT security documentation.

Confidential

Technical writer

Responsibilities:

  • Reviewed engineering documents and notes previously collected to write technical information entries about Remedy and then entered these writings in a new knowledgebase management system for Helpdesk engineers to reference in their work.
  • Wrote knowledge articles for service desk ITSM .

Confidential

Technical writer

Wrote and documents for a 21 CFR Part 11 electronic records, electronic signatures blood bank.

Confidential

Technical writer

Responsibilities:

Gathered software requirements from customers in order to complete design requirement documents.

Wrote procedures.

Wrote technical specifications for gas detection sensor computers.

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