SENIOR TECHNICAL WRITER
Technical writer experienced in a wide range of capacities and environments. Held multiple titles such as Senior Technical Writer, Quality Analyst, and Validation Specialist. Creating validation documents for engineering review, gate reviews and compliance entities. Supported engineering staff. Demonstrating the capabilities of technical writing in solving problems. Understanding of pharmaceutical and medical device validation and compliance documentation.
· Planning, analysis and construction of documents
· Familiarity with FDA guidelines, including 21 CFR
· Aware of the structure, content, number and implications of validation documents
· Communicating progress and goals to peers, subordinates and supervision
· Use of documentation change control
· Using project management to organize tasks and accomplish project goals
Montana Secretary of State's Office - Created SOPs, training materials and supporting software documentation (contractor)
Book Contributor for Simply Written - Book explains a proprietary information mapping method through a series of dialogues.
ITT Schools National Headquarters - Documented the recruitment module of their enterprise computer system. There were actually four periods of work during this year. Wrote SOPs and training for the sales force.
Safety Management Group - Edited company safety handbook.
Eli Lilly and Company (CREW, et al. - contractor role) 1999-2009
Held positions with these titles: Quality Analyst, Technical Writer, Senior Technical Writer, and Editor.
Worked in the following projects: Parenteral Trials Pilot Plant; Dry Products Packaging; Dry Products, Manufacturing; Clinical Trials Pilot Plant; Fermentation Optimization Pilot Plant; and Bioinfomatics
· Revised user documentation for a cutting-edge company-critical system used in clinical specimen management
· Assisted site SME in developing a dual site and plant-scope alarm strategy
· Created a solution for corruption in a document set
· Created and applied document library procedures; GMP Librarian
· Edited process automation, equipment validation, functional requirements, and design documentation
· Performed Periodic Reviews
· Prepared materials for gate reviews, and operating procedures for rooms, equipment and cleaning
· Revised and expanded a presentation about column packing
· Systematically revised documentation to reflect field changes
· Used document automation and macros to facilitate document editing and creation
· Used Rational Clearcase for document storage and revision tracking
· Worked to optimize documentation to facilitate report generation
· Wrote SOPs and training documentation
Technical Writer Motorola (Crew) 2006
For an RFP review by the Metropolitan Emergency Communications Authority (MECA) of the City of Indianapolis worked with project leadership and a corporate VP to revise RFP at issuer's request assisted with materials for a press conference.
Validation Specialist Boston Scientific (Pharmtech) 2007 - 2008
As part of a validation/remediation effort created Intended Use documentation and applied in-scope portions of 21 CFR
Ebook Author – Published ebooks via Kindle Direct Publishing, available on the Kindle Store, Amazon.com: “Brilliance-at-Twilight” (fiction) An alternative history of the City of Indianapolis; “The Golden Child” (fiction) A boy comes of age through his friendship with an elderly woman and the discovery of a walled garden; “Hybrid Airship/Aerostats for Orbital Use” (non-fiction) is a white paper, speculating on using lighter-than-air vehicles to achieve orbital flight
Book Co-author - "Network: Career Resources on the Internet" by Jane Lommel and Edgar Huntington was one of the first books about using the Internet for a job search.
The Art Institute of Indianapolis
Working towards a Web Design and Media Communications Certificate (expected 2013)
Aspen University Certificate - Project Management
Ball State University B.S. Economics; graduate work