Technical Writer Management

Profile:

Twenty-nine years’ experience, primarily as a Technical Writer, Document Change Control Specialist and Author/Editor. Experience includes:

Significant experience with 21CFR Part 11.

** *ears in GDP/GMP documentation and compliance environments.

Highly skilled at translating complex theories, obtuse Federal regulations and mechanics into easily understood written materials for diverse target audiences including:

oIT

oBest Practices

oStandard Operating Procedures

oDevices

oTraining

oWork Instructions

oFacilities Management

oWarehousing

oElectronic and Hard Copy User Forms

oSDLC

Researching and authoring feature articles and technical Q&A columns

Equally comfortable in the PC or Mac world

Highly competent user of:

oMS Word

oExcel

oVisio

oPowerPoint

oTrackWise

oSharePoint

oRemedy

oDocumentum

oMS Access

oPhotoshop

oAdobe Captivate

oEDMS

oQUMAS

oDISC

oINIT

oGeodIS

oChange Management

oSnagIt

oJIRA

Experience

LifeCell, An Acelity Company, Branchburg, NJ – 9/16 – 11/16

Documentation Specialist for Change Management group

Edit documents, process them through document management system, update electronic and hard copy files.

Sanofi Pasteur, Swiftwater, PA - 8/15 – 9/16

Technical Writer and Documentation Change Control for IT Groups

Recruited to return to the previous position that I held for almost five years, as a suitable replacement could not be found. I continued to assist in the creation of specific documents within our business unit, and provide documentation services for a wide range of business units within the IS group.

PP&L, Allentown, PA - 3/15 – 8/15

Documentation Specialist for the Electric Utilities Capital Projects group.

I joined the team to help produce and edit procedures, workbooks, guidelines, job aids, report definitions, templates and other documents. I also created a number of Visio workflow diagrams for the various activities my team was involved with. Additionally, I was involved in the approval process for our documents on this project.

Sanofi Pasteur, Swiftwater, PA - 3/10 – 3/15

Technical Writer and Documentation Change Control for IT Groups

Initially I was brought in to assist in the creation of specific documents within our business unit, but as the need for documentation and training materials expanded, coupled with my reputation for delivering quickly and with quality, so did my responsibilities. I was able to provide documentation services for a wide range of business units within the IS group.

Thanks to being familiar with many office software packages and systems, I was able to provide documents in Word, Excel, Visio, PowerPoint and a few others. Additionally, my familiarity with TrackWise and document management systems and the rules that govern their use enabled me to support the business need for document change management and tracking.

After taking a company-sponsored course, I could produce animated training materials using Adobe Captivate for a number of business units within the IS group. Along with creating training materials, I was asked to help train new hires and to support the training they received from the company-training group.

After moving to new office space I was tasked with several administrative roles within that office, liaising with access, provisioning, maintenance, housekeeping, supply and catering.

Aegis Limited, East Rutherford, NJ November 2009 – January 2010

Technical Writer

Created training materials for new IT Service Desk.

Created Quick Reference Cards for training.

Edited documents with author input.

Edited SME-authored documents for grammar, spelling and continuity.

Avaya, Basking Ridge, NJ - 6/09 - 8/09

Technical Writer

Wrote and edited system documents on SharePoint site for IT group.

Interviewed subject matter experts to develop system documents.

Created system diagrams and workflows.

Siemens, Iselin, NJ - 1/09 - 3/09

Technical Writer

Wrote and edited system documents on SharePoint site for Financial Services IT group.

Developed user manuals for lending systems.

Interviewed subject matter experts to develop system documents.

Created system diagrams and workflows.

Ernst & Young, East Rutherford, NJ - 8/08 - 12/08

Technical Writer/Editor

Wrote and edited documents for Information Security and Communications group.

Wrote articles for EY Innovation magazine and other internal publications.

Interviewed subject matter experts for magazine articles and documentation projects.

Developed user forms for research group.

Developed and published intranet site content for Information Security group and Research Zone.

Teleflex/Arrow, Reading, PA - 7/08 - 8/08

Technical Writer

Developed, formatted and updated documents, templates and spreadsheets for remediation project.

Supplied creative input to develop processes and practices for documentation remediation project.

Pfizer, Morris Plains, NJ - 9/06 - 5/08

Technical Writer

Edited project management documents with author input and published them to SharePoint site.

Created Power Point presentations and training materials for Project Management team.

Created Excel spreadsheets for project tracking tasks.

Assisted in the creation of user surveys for Telephony project.

Edited SME-authored documents for grammar, spelling and continuity.

Wrote SOPs and Work Instructions for validated systems including SharePoint and Ariba.

Bristol-Myers Squibb, Hopewell, NJ - 4/06 - 8/06

Technical Writer

Wrote SOPs and Work Instructions for validated systems.

Formatted document templates.

Developed document style guide.

Edited documents with author input.

Johnson & Johnson (NCS), Raritan, NJ - 3/06 - 4/06

Change Management

Processed system changes.

Closed change tickets.

Processed change metrics and posted results to web portal.

Roche Molecular Systems, Inc., Branchburg, NJ 10/03 - 3/06

Technical Writer/Document Change Control

Processed documentation using the Documentum QUMAS (NetDocs) system.

Tracked documents through all stages of life cycle; coordinated activities with authors, reviewers, and approvers to promote document flow through the system.

Trained new hires in the following: Word processing, Excel, Access, Documentum, and documentation distribution and document life cycle management.

Executed distribution workflow phase for new and revised documents.

Authored, reviewed, and revised technical documentation for multiple 21CFR Part 11 regulated business units within company, including Development, Operations, Regulatory, Facilities Management, Bioprocessing, Bulk Manufacturing, Detection Formats, Environmental Monitoring, PCR Controls, Warehousing and Distribution.

Maintained documentation master files and provide master file research.

Assisted authors and reviewers with validation documentation responsibilities.

Worked on special projects for the documentation management and labeling groups.

Additional Experience

Ingenix Inc., Parsippany, NJ 11/02 - 6/03

Technical Writer

Schering-Plough Corp., Madison, NJ - 9/02 - 11/02

Technical Writer

Ortho Clinical Diagnostics, Raritan, NJ - 9/98 - 11/00

Technical Writer/Document Change Control

Tracked documents through all stages of life cycle; coordinate activities with authors, reviewers, and approvers to promote document flow through the system.

Trained new hires in the following: Word processing, Excel, Access, Documentum, documentation distribution and document life cycle management.

Executed distribution workflow phase for new and revised documents.

Authored, reviewed, and revise technical documentation for multiple 21CFR Part 11 regulated business units within company, including Development, Operations, Regulatory, Facilities Management, Bioprocessing, Bulk Manufacturing, Detection Formats, Environmental Monitoring, PCR Controls, Warehousing and Distribution.

Maintained documentation master files and provide master file research.

Assisted authors and reviewers with validation documentation responsibilities.

Worked on special projects for the documentation management and labeling groups.

Publishing Experience

Examiner.com 7/09 – 7/15

Allentown Classic Car Examiner

Researched, wrote and published automotive web page articles.

Specialty Equipment Market Association (SEMA) 11/00 - 6/02

Online Technical Editor, www.enjoythedrive.com.

Answered automotive technical question e-mails from consumer website.

Researched and wrote articles for consumer website.

Special Achievement: answered 1,600 consumer inquiries in 17 months.

CSK Publishing Company, Saddle Brook, NJ 12/89 - 5/92

Senior Editor

Wrote, edited, and solicited articles for publication in multiple automotive consumer publications. Responded to subscribers' technical inquiries. Wrote bi-monthly columns. Performed mechanical work for technical articles. Contacted suppliers for participation in joint projects. Photographed and reported on special events. Supervised art direction.

Education

Raritan Valley Community College, North Branch, NJ

Associate of Applied Science in Legal Assisting, GPA 3.35, May 1997

Special Achievement: Dean's List 4 times, National Honor Society 2 times.

Contact this candidate