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Technical Writer Medical Device

Location:
San Jose, CA
Posted:
October 12, 2020

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Resume:

Linda Cunningham cell 925-***-****

*** **** ***, *** **** CA 95134 adgwna@r.postjobfree.com

Professional Profile

Technical Writer

Over ten years of experience authoring hardware and software documentation

Edited documentation to ensure consistent corporate style and standards

Wrote manuals for Class 1 Medical Device

Authored IQ/OQ protocols FDA 21 CFR 210/211

Microsoft Office, FrameMaker, Adobe Acrobat, Doc to Help, RoboHelp, Snagit

Analytical Chemist

HPLC, LC/MS and other instruments

Analytical Method Validation

Authored Chemistry section for CMC

PTI class on AIQ,

GMP, GLP, USP

ACS short course Project Management

ASMS short course Practical LC/MS

Technical Trainer for Waters

Authored Using Empower for 21 CFR part 11

Authored SOPs and ATMs

Professional Experience

Senior Technical Writer–Thermo Fisher Scientific San Jose, CA

June 2017 – present

Created Manuals (PDFs) and help files (.chm) for TSQ Mass Spectrometers RUO.

Create Manuals (PDFs) and help files (.chm) for Class 1 Medical Device Mass Spectrometer.

Created LC/MS for Technical Writers class for co-workers.

Used Confluence, Microsoft Teams, SharePoint, FrameMaker, Adobe Acrobat Pro.

Technical Writer Contract– Aerotek/Gilead Foster City, CA

December 2016 – June 2017

Completed training required for cGMP.

Creating eForm for Certificate of Analysis.

Technical Writer – Tri Tool Inc. Rancho Cordova

June 2013 – May 2016 (layoff)

Published user manuals and technical specifications from Solid Work drawings and other materials.

Updated the format of the user manuals and technical specifications. Managers appreciated my creativity to unite Web presence with hard copy documents.

Managed multiple priorities from staff of 10 engineers.

Technical Writer Consultant- Volt/Agilent Technologies

March 2011 – June 2013 (contract ended)

Created Agilent OQ and PM protocols from Varian documents.

Wrote OQ and PM Work Instructions for instruments that are part of the Agilent ACE program.

Collaborated with Agilent service engineers and managers world-wide.

Used Team Track and Clear Case for document control.

Technical Writer Consultant – Aerotek and Adecco

September 2010 – March 2011

Impax Laboratories: Used SharePoint to revise SOPs to include SAP.

BD Biosciences: Used FrameMaker to edit manuals for software revision.

Technical Writer- Varian, Inc, Walnut Creek, CA. – now Agilent Technologies

July 2005 –September 2010 (layoff)

Managed and edited documentation suite for introduction of new mass spectrometers.

Used Controlled English to facilitate communication with global customers and field service.

Developed IQ and OQ documents, 21 CFR Part 210, 211 and 11.

Collaborated with Technical Support, Applications, and Marketing in US, Holland, and Australia to create IQOQ documents and manual templates.

Provided IQOQ training and phone support for service engineers.

Technical Trainer - Waters Corp., Milford, MA

June 2001 – April 2004

Created and delivered custom Empower training class for Pfizer in England and San Diego.

Wrote Using Empower/Millennium in Regulated Environment (cGMP 21 CFR part 11) manual

Training Classes: Train the Trainer, Empower/Millennium Basic and Advanced Techniques, PDA, Waters LC/MS.

Provided on-site Millennium and Empower customer training in U.S., Canada, and England.

Wrote and edited manuals for Empower, PDA, and Regulated Environment.

Research Scientist - ArQule, Inc. Woburn, MA

November 1999 – June 2001

Developed ESI ionizations methods to standardize results for several different single quad MS systems.

Troubleshot and interpreted LC/MS data of combinatorial libraries.

Supported discovery efforts by developing ionization methods, acquiring and interpreting LC/MS (ESI and APCI) data (Micromass and Waters) of small molecule samples from 60 chemists.

Maintained and troubleshoot HPLC and LC/MS instruments and was contact person for MS field service.

Scientist - Synaptic Pharmaceutical Corp., Paramus, NJ

March 1998 – October 1999 (layoff)

Evaluated and installed OpenLynx Browser software for Chemistry group.

Trained Chemistry group on operation of OpenLynx Browser.

Decreased turnaround time for combinatorial libraries by 25%.

Acquired and interpreted LC/MS data for combinatorial libraries and peptides.

Maintained and troubleshoot HPLC and LC/MS instruments and was contact person for MS field service.

Trained co-worker to operate Waters/Micromass LC/MS system.

Scientist - Trega Biosciences, San Diego, CA

May 1997 – February 1998 company no longer in business

Evaluated beta version of combinatorial browser software.

Acquired and interpreted LC/MS data for combinatorial libraries.

Scientist - Alanex Corporation, San Diego, CA

July 1994 – April 1997

Developed LC/MS methods for peptides.

Acquired and interpreted LC/MS data for combinatorial libraries and peptides.

Maintained, calibrated, and troubleshoot Waters/Finnigan LC/MS instrument.

Education

BS Biology: Mount St. Mary’s College, Los Angeles, CA

MS Biochemistry: Long Beach State University, Long Beach CA

Doctoral Candidate Clinical Chemistry, Louisiana Medical Center, New Orleans LA

Publication

Cunningham, Linda. "Gems from the Writing Boot Camp” Devil Mountain Views: Newsletter of the East Bay Chapter of STC March/April 2008.

References

References are available upon request.

Writing Samples

Available upon request.



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