PROFESSIONAL SUMMARY:

My career is in documentation, technical writing and illustration with electro-mechanical drafting as a foundation. Prior responsibilities include a diverse background of technical documentation within manufacturing, research, life science/pharma, and product development organizations.

History Overview Includes:

• Technical Writer for Shire Corporation initiating cGMP documentation related to Facilities and Engineering.
• Technical Illustrator/Writer contract at MagneMotion, Inc. creating work instructions and method sheets.
• Technical writing/project coordinator for Zentek Automation at Genzyme performing quality review of engineering specifications, client transmittals, and maintaining Excel spreadsheet of document deliverables database and hard copy quality document files for management
• Marioff Corp. technical data sheets using digital images and graphics of fire suppression systems used for field equipment installation
• Hardware and software documentation set for the PanelPrinter photolithography system creating text, digital images, and graphics for Azores Corporation
• Medical writer, MediSense/Abbott and Pall Corporation product user guides, collateral product inserts, system description manuals, software field upgrade manuals, and participation in consumer product alpha testing using digital images and graphics
• Polaroid's Communication Services organization and Film Manufacturing Division, providing technical writing and illustration of film processes, production equipment procedures, and collateral graphics
• Minor miscellaneous roles in-between long term positions filling in unrecorded gaps.

I have a professional attitude and aptitude and work well in a team environment or as an individual contributor. My skills and background experience are transferable to most industries in engineering and life science documentation clean-room experience prior secret clearances held.

APPLICATION TOOLS:

MS Office - Word, Access, Power Point, and Excel. Adobe Illustrator, FrameMaker, PhotoShop, Acrobat, and Visio. Minimal Experience Using: Dreamweaver, RoboHelp, SolidWorks, SharePoint experience.

PROFESSIONAL EXPERIENCE:

Technical

Confidential .

• Develop and revise control documentation in accordance with cGMP standards. Responsible for GMP and non-GMP process documentation in support of F E to initiate and revise SOPs, Engineering Procedures, and project collaterals. Coordinate and review documentation and consult with managers and SMEs within project groups including liaison with Training and Document Control ensuring appropriate generation of support materials.
• Technical Illustrator/Writer - Contract Confidential Create work instructions and operational method sheets for manufacturing assembly of electro-mechanical magnetic motion devices with the direction of the Engineering and Technical Publication's lead. Technical Writer/ Project Coordinator Confidential Document/Quality lead and cGMP/SOP standards, conduct quality review and corrections to documentation submitted from engineering prior to processing transmittals for Genzyme client/engineering review and approval. Maintain hardcopy and electronic files in the document lifecycle within change control systems and policies. Technical Writer - Independent Contractor Confidential Create technical data sheets and system manuals of fire suppression equipment and collateral documentation containing edited digital images and Solid Works engineering drawings.

Confidential

• Prepare source text using FDA and Abbott literature standards and guidelines for user guides and collateral product inserts associated with diabetes diagnostic products.
• Production and Inventory Control Coordinator Prior responsibilities: Corporate Shipping and Receiving Clerk.
• Lead ISO certification effort in populating documentation database, upload application software to PCs, disseminating quality guidelines and information to employees.
• Create and update Abrasive Flow Machine BOM entries into MAPICS application from electrical and mechanical engineering inputs / production meeting scribe.
• Documentation Specialist Confidential Produce corporate ISO procedures, work instructions, job descriptions, and documentation logs.
• Assist with creating validation documentation: Installation qualification, operational qualification, and factory acceptance testing documents.
• Validation and Documentation Specialist Confidential Produce operating and system description manuals, containing digital images and graphics of pharmaceutical filtration and separation processing systems following cGMP practices.
• Conduct documentation review meetings and information gathering from engineering.
• Writing, editing, and digital image capture and placement used in operation, calibration, maintenance procedures, and GUI manuals for large, flat-panel display photolithography systems. Clean-room assembly area environment access.
• Create artwork, screen shots, and reference product illustrations for user guide drafts.
• Prepare monthly status reports, project plans, and Labeling department guidelines and processes.

PRIOR EXPERIENCE:

• Provide camera manufacturing and test equipment assembly drawings, pneumatic and schematic diagrams, and perspective artwork. Create mechanical drawings of camera devices using ANSI geometric tolerance and welding standards.
• Design Layout Drafting - Produce design and assembly drawings of equipment used in solar cell manufacturing, nuclear materials, and plasma physics. Lab and test site setup technician at Brookhaven Laboratories LI, NY.
• Organize and prepare new product specification documentation and reliability procedures. Perform film material defects testing in clean room environment. Create artwork and write process development and laboratory setup procedures.
• Prepare written material and technical line art for installation and adjustment procedures, operational bulletins, and collateral material. Safety and environmental core team member, ISO 9000 Lead Auditor.
• Bench hand de-burring aircraft components and machine tool grinder.