Linda Cunningham Email & Phone Number

South San Francisco, California, US

Writing documents in support of Medical Device filling with FDA and EU

Fremont, CA, US

I am writing user manuals for the ForteBio instruments

Waltham, MA, US

Sr. Technical Writer for TSQ Mass SpectrometersWrote Manuals for Class 1 Medical Device- regulatory requirements for US FDA and EU IVDRCollaborated with SMEs in Marketing, Product Evaluation, R&D and RegulatoryQSR Training

Foster City, CA, US

Completed training required for cGMPCreating eForm for Certificate of AnalysisUsed Documentum for EDMS

Rancho Cordova, CA, US

• Tri Tool makes equipment for the oil and gas industry. Due to low oil prices Tri Tool is having lay offs.
• Published user manuals and technical specifications from Solid Work drawings and other materials provided by engineers.
• 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.
• Adobe Creative Suite InDesign, Adobe Illustrator, Photoshop, Bridge, and Adobe Pro as well as Word and Excel

Orange, CA, US

Wrote qualification protocols for service engineersWrote Work instructions for software based protocolsResearched instruments to obtain performance maintenance parts.Managed mutiple projects with SMEs around the worldUsed Microsoft Office and ClearCase

US

• Layoff September 2010ACHIEVEMENTS
• 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 Marketing and Tech Support to reformat Pre-installation Instructions for global customers.RESPONSIBILITIES
• Developed strong working relationships with subject matter experts in all departments.

Milford, MA, US

• ACHIEVEMENTS
• 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 for customer training classes.
• Training Classes: Train the Trainer, Empower/Millennium Basic and Advanced Techniques, PDA, Waters LC/MS.RESPONSIBILITIES
• Provided on-site Millennium and Empower customer training in U.S., Canada, and England.
• Wrote and edited manuals for Empower, PDA and Regulated Environment.

• ACHIEVEMENTS
• Developed ESI ionizations methods to standardize results for several different single quad MS systems.
• Troubleshot and interpreted LC/MS data of combinatorial libraries.RESPONSIBILITIES
• 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, calibrated, and troubleshoot HPLC and LC/MS instruments and was contact person for MS field service.

• ScientistACHIEVEMENTS
• 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%.RESPONSIBILITIES
• Supported discovery efforts by developing ionization methods.
• Acquired and interpreted LC/MS data for combinatorial libraries and peptides.

US

• Alanex Corporation, San Diego, CAJuly 1994 – April 1997 ScientistACHIEVEMENTS
• Developed LC/MS methods for peptides.
• Modified Waters/Thermo LC/MS system for combinatorial libraries.RESPONSIBILITIES
• Supported discovery efforts by developing ionization methods.
• Acquired and interpreted LC/MS data for combinatorial libraries and peptides.
• Maintained, calibrated, and troubleshoot Waters/Finnigan LC/MS instrument.

Analytical Method ValidationCharacterization of Monoclonal AntibodyAuthored SOPs

Bachelor’S Degree, Biology/Chemistry

Ms, Biochemistry