Technical Communications Professional

EXPERIENCE

Express Professionals

Mason, OH

*/**** – 9/2008

Tax Documentation

Archivist

Contract Position

Sorted for archive the business and resident tax files for the community of Mason, OH.

Processed for archive daily and weekly letters and loose item documents.

Processed hard copies of monthly, quarterly and yearly tax returns, withholding statements, cancelled check payments or receipts-of-payment, transient returns and refunds into the city finance database.

Indexed electronic copies into appropriate file locations in the database.

Arranged and archived hard copies of monthly, quarterly and yearly tax returns, withholding statements, cancelled check payments or receipts-of-payment, transient returns and refunds.

Kirby-Risk Electrical Supply

Indianapolis, IN

1/2007 – 4/2008

Delivery and Logistics Specialist

Full Time Position

Inspected and operated 15’, 24’ and 28’ cargo and box trucks.

Inspected and loaded daily orders, comparing them against daily-generated customer orders.

Generated daily manifests based upon loaded customer orders.

Delivered customer orders on a daily route covering an average of 400 miles each day.

Developed positive relationships with customers at each client delivery location.

Operated route delivery over 18 months with only two vehicular incidents, both involving unavoidable situations with no injuries to personnel or property damage.

Processed and transported materials to route specific company stores and company sites, following daily generated transfer orders.

Cooperated with store clerks to fulfill daily transfer orders.

Operated fork trucks, skid lifts and pallet jacks as necessary to move materials during the course of an average day.

Generated loss of material and non-received material reports as necessary.

Maintained DOT and insurance required physical health inspections and local licensing requirements.

Staffworks Employment Solutions, Inc.

Indianapolis, IN

3/2006 – 1/2007

Warehouse Logistics Associate

Contract Position

Processed and moved materials to specific warehouse locations, following daily generated receiving manifests.

Cooperated with warehouse receiving and shipping clerks to reconcile manifests and bills of lading against stored and shelved materials.

Operated fork trucks, skid lifts and pallet jacks to move materials during the course of an average day.

Generated loss of material and non-received material reports as necessary during the course of an average day.

Solution Technology, Inc.

Indianapolis, IN

1/2006 – 3/2006

Computer Assembly and Customization Specialist

Contract Position

Assembled, disassembled and created desktop and laptop systems per specific customer orders and requirements. These system configurations could include changes to system hardware, software, Operating Systems, BIOS and CMOS settings.

Customized system hardware to include customer specific labeling, security data labels, anchoring assemblies and hardware profiles to fulfill specific customer orders.

Followed first party and third party client requirements for system assembly and configurations.

Produced specially configured and assembled computer systems for third party clients such as the US Social Security Administration, US Department of Education, Multiple State and Local Education Departments and corporate entities such as Hewlett Packard, Inc.

Crew Technical Services

Indianapolis, IN

8/2005 – 10/2005

Technical Writer

Contract Position

Produced Validation documents following client CSV policies and procedures and FDA regulations.

Produced Software support documents including client and administrative specifications.

Audited validation documentation for compliance with client CSV and FDA acceptability criteria.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Incorporated applicable system engineering changes into the documents.

Used MS Office, Visio, Adobe Acrobat, Photoshop, and Illustrator to develop the documentation packages.

Supported teammates as a testing and validation resource.

Pinnacle Partners Inc.

Indianapolis, IN

5/2005 – 8/2005

Technical Writer

Contract Position

Produced End-User support documents using “How-to” and “Step-by-step” formats.

Produced Software support documents including client and administrative specifications.

Developed document templates based on project need and the appropriate Quality Assurance policies and procedures.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Incorporated System Engineering changes into the documentation.

Used MS Office, Adobe Acrobat, Photoshop, Illustrator and Visio to develop the documentation packages.

Produced Design illustrations using Visio.

Supported teammates with editing and writing on semi-completed projects as well as providing a documentation direction resource.

Safis Solutions, LLC

Indianapolis, IN

6/2004 – 12/2004

Compliance Consultant

Contract Position

Produced Validation documents following client CSV policies and procedures and FDA regulations.

Produced Software support documents including client and administrative specifications.

Audited validation documentation for compliance with client CSV and FDA acceptability criteria.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Incorporated applicable system engineering changes into the documents.

Used MS Office, Visio and Adobe Acrobat to develop the documentation packages.

Supported teammates as a testing and validation resource.

IT Spire, Inc.

Indianapolis, IN

3/2004 – 6/2004

Technical Writer

Contract Position

Produced End-User support documents using “How-to” and “Step-by-step” formats.

Produced Software support documents including client and administrative specifications.

Developed document templates based on project need and the appropriate Quality Assurance policies and procedures.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Incorporated System Engineering changes into the documentation.

Used MS Office, Visio and Adobe Acrobat to develop the documentation packages.

Produced Design illustrations using Visio.

Supported teammates with editing and writing on semi-completed projects as well as providing a documentation direction resource.

MGT & Associates

Indianapolis, IN

10/2003 – 3/2004

Technical Writer

Contract Position

Updated Software Design documents for an insulin production plant in Puerto Rico per customer changes and feedback. Some of these documents exceeded 2000 pages.

Provided Final Technical Review of Software Design Documents for the insulin plant.

Used MS Office, Adobe Acrobat, Photoshop, and Illustrator to write, edit and update documents.

Produced Design illustrations using Visio.

Created company resumes in Cornerstone Controls Inc. format

Created a Programming Standards document based off of three previous documents.

Proofread and edited documents as necessary.

Maintained internal company documentation.

Provided support for other team members.

Computer Task Group

Indianapolis, IN

5/2003 – 10/2003

Validation Technical Writer

Contract Position

Edited existing Validation documents for Customer Support Automated Systems using client’s latest validation policies and procedures to ensure compliance.

Used MS Office, Adobe Acrobat, Photoshop, and Illustrator to develop the validation packages and subsequent documents required for system validation.

Provided documentation coverage for all main systems and major subsystems being used inside the Customer Support Center by adhering to FDA regulations including and especially CFR 21, all appropriate client Quality Assurance SOP’s, and Local policies and procedures.

Defined, developed, designed and updated documentation for Customer Support Center operation systems which includes appropriate and needed site SOP’s, qualification documents, test plans and cases, and related dialog documentation.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Alliance Technologies Group

Merrillville, Indiana

11/2002 – 5/2003

Technical Writer

Contract Position

Produced Software support documents including code related machine specifications.

Developed document templates based on project need and the appropriate Quality Assurance policies and procedures.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Incorporated System Engineering changes into the documentation.

Used MS Office, Visio and Adobe Acrobat to develop the documentation packages.

Edited existing documents for affected systems.

Supported teammates with editing and writing on semi-completed projects as well as providing a documentation direction resource.

Computer Task Group

Indianapolis, IN

1/2001 - 7/2002

Validation Technical Writer

Contract Position

Edited existing Validation documents for Pilot Plant Automated Systems using client’s latest validation policies and procedures to ensure compliance.

Used MS Office, Visio, Adobe Acrobat and specific Rockwell Automation utility and logic systems to develop the validation packages and subsequent documents required for system validation.

Provided documentation coverage for all main systems and major subsystems being used inside the pilot plant by adhering to FDA regulations including CFR 21, all appropriate client Quality Assurance SOP’s, and Local policies and procedures.

Defined, developed, designed and updated documentation for production plant operation systems which includes appropriate and needed site SOP’s, qualification documents, test plans and cases, and related dialog documentation.

Maintained a project library (Hard Copy and Electronic) to store and organize existing re-vamped documents as well as new documents prior to Quality Assurance acceptance. The documents stored here were completed and semi-completed project documents including secondary support documents.

Developed document templates based on project need and the appropriate Quality Assurance SOP’s and Validation policies and procedures.

Interacted with associated Engineers, Developers, and Product End-users to assure project completion.

Assisted in coordinating and managing documentation projects for Production Plant Systems. In addition; provided a timely status report on project documents based upon each individual system and its projected validation deadline, and routed documents through the correct review and approval processes. Also monitored the review and approval processes to assure a timely turnaround on affected documentation.

Worked with ER/ES Security Team to assure that all electronic records and security concerns were addressed.

Supported teammates with editing and writing on semi-completed projects as well as providing a documentation direction resource.

System Design Group

Indianapolis, IN

3/2000 - 1/2001

Technical Writer

Full Time Position

Wrote and updated validation documentation for software and automated system hardware.

Assisted in creating templates for Requirement Specification, SUIT, and other associated documentation for software projects.

Used Adobe Acrobat, Photoshop, Pagemaker 5.0, Illustrator, MS Outlook, Word Powerpoint, Windows 95, NT and Visio.

Assisted in equipment setup and testing of test stands.

Interacted with print vendors.

Directed daily office operations.

Talent Tree/Initial Staffing

Indianapolis, IN

6/1999 - 3/2000

Desktop Publications Specialist

Contract Position

Updated and prepared product labels and Product Inserts for Engineering changes which include Corporate ID, new product releases, visual reworks, and new label creation.

Wrote and Updated Product Inserts for Engineering/Chemical changes which include new product releases and visual reworks.

Assisted the Global Labeling Writers with product inserts and other product documentation as necessary.

Used Adobe Acrobat, Photoshop, Pagemaker 5.0, Illustrator, MS Outlook, Word, Powerpoint, Windows 95, NT and Visio.

Ferno-Washington Inc.

Wilmington, OH

4/1994 - 4/1999

Senior Technical Writer

Full Time Position

Wrote Service, Installation, and Users’ manuals for emergency, mortuary, and therapy products. The FDA regulated all written products.

Produced, wrote, and directed product videos for marketing and training purposes. Reduced budget needs for videos by 60%.

Worked with video editing on digital platform to produce master copy.

Assisted in creating a template for Users’ and Service manuals and parts kits instructions.

Developed and implemented a manual template for product installation manuals.

Designed instructional labels and Product Data Sheets for ISO-9000, European Union, and NHTSA specifications.

Coordinated with and assisted the Advertising and Marketing groups with support documentation.

Interacted with both internal and associated Engineers, Assemblers, Designers, and Marketing Managers.

Coordinated project printing with vendors.

Effectively coordinated and managed the repair and service manuals for a corporate division.

Used Adobe Acrobat, Photoshop, Pagemaker 5.0, Illustrator, MS Outlook, Word, Powerpoint, Windows 95, NT and Visio.

EDUCATION

Master's Degree(History) - Almeda University - US-ID-Boise, Online Program 9/2003

Bachelor's Degree (English/History) - Wilmington College - US-OH-Wilmington 6/1994

Comptia A+ Certification (2000)

FDA Regulations

Title 21 CFR; 10 – Administrative practices and procedures

11 – Electronic Records and Electronic Signatures

58 – Good Laboratory Practice for non-clinical laboratory studies

369 – Interpretive statements regarding warnings on drugs and devices for over-the-counter sale

680 – Additional Standards for Miscellaneous products

801 – Labeling (Medical Devices)

803 – Medical Device Reporting

806 – Medical Devices; Reports of corrections and removals

807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

812 – Investigational Device Excemptions

814 – PreMarket Approval of Medical Devices

820 – Quality System Regulation

821 – Medical Device Tracking Requirements

822 – PostMarket Surveillance

860 – Medical Device Classification Procedures

861 – Procedures for Performance Standards Development

880 – General Hospital and Personal Use Devices

890 – Physical Medicine Devices

Skill Name/Skill Level/Experience

A+ Certification/Expert/7 years

Adobe Acrobat/Intermediate/9 years

Windows 98/Intermediate/10 years

Windows XP/Intermediate/6 years

Adobe Photoshop/Intermediate/15 years

Adobe Pagemaker 5.0/Expert/15 years

Adobe Illustrator/Intermediate/11 years

MS Outlook/Intermediate/11 years

Windows 95/Intermediate/13 years

Windows NT/Intermediate/15 years

MS Word/Expert/15 years

Visio/Expert/15 years

MS Powerpoint/Expert/15 years

MS Excel/Intermediate/15 years

References available upon request.

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