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Technical Writer/compliance Sme Resume

Berkley Heights, NJ

SUMMARY:

  • Over twenty - five years experience doing the following developing, editing, writing, & proofreading a variety of end-user documents including Confidential certified site documentation
  • Equipment & utility qualification protocols and validation,
  • Project coordination and management,
  • Operation & maintenance manuals, safety manuals, installation & service manuals,
  • Automotive computer-based training (CBT) courses and instruction manuals,
  • Document control and management,
  • Electronic records and electronic signatures (ERES), cGMP process & packaging validation documents, cGxP computer validation,
  • IQ/OQ/PQ documents,
  • Request for proposals (RFPs),
  • Computer setup & installation instructions,
  • Standard operating procedures (SOPs),
  • In-house documents & forms, questionnaires, and instruction sheets;

TECHNICAL SKILLS:

Hardware Used: AS/400 mainframe; IBM compatible & Macintosh Systems; flatbed scanners; digital cameras

Software Used: MS Office (MS Word, MS Excel, Access, Powerpoint), Visio, SAP, Oracle database, FileMaker Pro, Minitab, Documentum, Microsoft Outlook, Visibility (Oracle Database), Windows 95, 98, ME, 2000, NT & XP; NetWare, Word Perfect 5.1 & 6.0; PageMaker; Quark Xpress; Adobe Illustrator; Freehand 3.1; PhotoShop, Canvas 4.0; MiniCad 7.0; AutoCAD r11, r12, r14; Personal Designer

EMPLOYERS:

Confidential, Berkley Heights, NJ

Technical Writer/Compliance SME

Responsibilities:

  • Duties include writing project documents, procedures and work instructions for the Confidential Global Supply Business Technology Global Business Intelligence team using cGMP and GDP; review documents for compliance with Confidential and Confidential requirements; interviewing and information gathering to build new documents for project requirements; used ALM to create Requirement Verification Strategy (RSV) documents.
  • Managed team documents in PDOCS (Documentum; storage of controlled documents) and SharePoint (storage of uncontrolled documents).

Confidential, Grand Rapids, MI

Technical Writer

Responsibilities:

  • Duties included writing plating and coating inspection instructions; create freehand drawings, used digital SLR camera to illustrate defects and processes; used Photoshop and Lighthouse to edit and manage images; interviewing and information gathering.

Confidential, Grand Rapids, MI

Technical Writer

Responsibilities:

  • Duties included writing equipment qualification protocols and final reports; assisting with validation executions; interviewing, and information gathering; project management.

Confidential, Grand Rapids, MI

Validation Engineer

Responsibilities:

  • Duties include redesigning protocol templates; running and assisting with validation executions; interviewing, information gathering, and writing protocols and final reports for equipment and utility qualifications.

Confidential, Grand Rapids, MI

Document Management Technician

Responsibilities:

  • Duties included analyzing and gathering information from documents to populate metadata fields; scan documents; ingest (process) into TeleScope program (asset management software); report document and data anomalies to manager; create document tracking spreadsheet; document coordination and management.

Confidential, Grand Rapids, MI

Validation Specialist

Responsibilities:

  • Duties include researching project documents to create process validation protocols and reports for manufacturing practices.
  • Documents used to ensure required validation exists according to Confidential Regulations and cGMP guidelines assist other validation specialists with data entry and data analysis for their reports and protocols; used SAP and Oracle to track product components used in validation activities; create process flow charts using Visio; used SharePoint to track and store approved documents, developed and administrated team folder structures and assigned permissions coordinated with Document Control to scan Validation documents including legacy documents into SharePoint before returning documents to Document Control.

Confidential, Grand Rapids, MI

Senior Technical Writer

Responsibilities:

  • Duties included researching and analyzing project documents to create a qualification summary report for test scripts executed for 3 JDE modules with interfaces, configurations, and enhancements to a legacy system; quantified test scripts; interviewed project SMEs; and prepped documents for electronic imaging and storage.
  • This document was used to assess required validation documents for Confidential Regulations and cGMP.

Confidential, Grandville, MI

Freelance Document Archive Specialist

Responsibilities:

  • Assisted with archiving client documents for Confidential disabled person's homes whose operations had been transferred to another agency.
  • Duties include copying, logging, and organizing documents before packing them for storage or destruction according to their record retention policy.

Confidential, Walker, MI

Special Projects Coordinator Assistant

Responsibilities:

  • Assisted Special Projects Coordinator with scheduling and checking in of special projects into FileMaker Pro database.
  • Help with mailings to service reps.
  • Help business managers with other activities such as digital photography of products for online instructions, proofreading, printing and trimming signs, and laminating.

Confidential, Grand Rapids, MI

Validation Specialist

Responsibilities:

  • validation document and project coordination, validation document creation and management; responsible for coordinating the OTS software validation with project group; learned about Lean Six Sigma practices while in this position.

Confidential, Grand Rapids, MI

Technical Writer

Responsibilities:

  • Contracted to write a segment of online help for software being developed for a charter school association.
  • RoboHelp Office X4 and Office XP were used to produce this online help.

Confidential, Indianapolis, IN

Technical Writer

Responsibilities:

  • validation document coordination, document control, and management using Documentum; writing SOPs; received training pertaining to CFR 21 Part 11; using and maintaining Word templates; and transcribed assessment meetings.

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