LANE NELSON COPLEY

lcopley@gmail.com (415) 279-4193 San Francisco, CA

Technical Writer, Software QA Engineer and GxP Validation Consultant

 

Looking for an interesting hardware and software processes and procedures documentation or QA project which fully uses my experience, education, talent and energy in a way which is technically challenging and demands constant educational growth.

TECHNICAL SKILLS

 

·         Full experience with the complete SDLC (several projects)

·         Experience with full Agile and mixed Agile development schemes

·         Programming Languages: Java/Android, C#/.NET

·         Operating System: Windows, Android (did the coursework for UNIX sysadmin through UC Extension, but never used it)

·         Development environments: emacs, Visual Studio, Eclipse, Android Studio

·         Defect tracking software: TestTrackPro, Microsoft Team Foundation Server

·         Automation scripting: Microsoft Test Manager, custom test scripts in WSH

·         Semiconductor technical writing experience

·         Software technical writing experience

·         Consumer product technical writing experience

·         Regulatory experience (FDA-regulated GLP methods validation, GMP processes and equipment validation and GCP  device software testing)

EXPERIENCE

KAISER PERMANENTE

Technical Writer.................................................................................................................................................. 2016

·         Assembled, edited, reformatted, proofread and wrote disaster recovery runbook documents for Kaiser Permanente in Pleasanton (working for a temp agency, which supplied me to Tata Consulting Services, contracted to KP).

KILOPASS                                                                                                                                             SAN JOSE, CA

Technical Writer.................................................................................................................................................. 2016

·         Edited, proofread and reformatted Test Methodology Design Guide and Data Sheet for a provider of non-volatile memory circuitry designs to improve usability and branding consistency

BIO-RAD LABORATORIES                                                                                                                  HERCULES, CA

Software QA Engineer/Technical Writer......................................................................................................... 2005-2015

·         Quickly found major defect sources in blocks of code by ad hoc testing in a session-testing environment

·         Wrote whole test plans from software requirements specifications for several projects at a time

·         Wrote test cases from test plans which trace to software requirements specifications

·         Executed tests from test cases, providing timely feedback through prompt, complete defect recording and tracking in an Agile environment

·         Test lead on two robot projects (one firmware-based, one Windows-based); wrote test plans, test cases, test reports and release recommendations

·         Test lead on firmware-based PCR instrument; wrote test plan, test case, test report and release recommendation.

·         Provided direction to software developers creating automated testing software from a SQA point of view

·         Created test harness (not related to the above test software) for execution of scripted UAT and BVT with excellent notification features (distributed e-mail if all passed, SMSed operator only if any test failed)

·         Prevented enormous loss of time and money by calculating the expense of fully validating existing product line in a mixed environment (approximately two man-years saved)

·         Instituted virtual machine testing using VMware images; later automated testing using these images

·         Verified data integrity over command-line interfaces through rigorous test planning and execution.  The command-line interface was later replaced with a full API

·         Provided meaningful feedback for UI development from the customer POV

·         Installed, tested, verified and validated firmware components of several complex instrument controls, including heating/cooling controls, robotic stepper systems, heated lid and motor systems, I2C communication devices, USB hubs and cameras in the context of providing end-to-end verification of instrumentation systems

·         Verified microscope camera data integrity in Android kiosk-mode touchscreen-controlled fluorescent cell imaging device

TriCN                                                                                                                                          SAN FRANCISCO, CA

Contract Technical Writer..................................................................................................................................... 2004

·         Revised and edited datasheets and application notes for a small telecommunications semiconductor design company as part of their re-branding effort (they wanted to be bought out)

·         Created document tracking system and specified new technical documentation software (FrameMaker and Visio)

BIO-RAD LABORATORIES                                                                                                                  HERCULES, CA

Temporary Technical Writer........................................................................................................................ 2003-2004

·         Wrote and edited software APIS

·         Wrote and edited software design specifications

·         Wrote and edited software life cycle documents

·         Wrote and edited software release specifications and procedures

·         Wrote and edited user guides

·         Wrote and edited ISO 9001 compliance documents (SOPs and work instructions)

EMANTRAS                                                                                                                                           SAN JOSE, CA

Temporary Technical Writer........................................................................................................................ 2002-2003

·         Wrote and edited product bulletins

·         Wrote and edited software specifications.

·         Wrote and edited user guides for a line of personal media devices

NUCORE TECHNOLOGY                                                                                                                   SUNNYVALE, CA

Contract Technical Writer..................................................................................................................................... 2002

·         Wrote and edited data sheets

·         Wrote and edited hardware reference manuals for the analog front end and digital back end of digital imaging products

EQUATOR TECNOLOGIES                                                                                                                   CAMPBELL, CA

Contract Technical Writer..................................................................................................................................... 2001

·         Wrote marketing copy

·         Edited data sheets and application notes

·         Wrote product bulletins

·         Documented the software APIs of a whole family of video processors

SAGE                                                                                                                                                    SAN JOSE, CA

Technical Documentation Director................................................................................................................ 2000-2001

·         Managed deadlines for firmware and register specifications

·         Wrote product bulletins

·         Edited application notes and data sheets for display processors

SILICON MAGIC                                                                                                                                 CAMPBELL, CA

Technical Writer......................................................................................................................................... 1998-2000

·         Researched and wrote documentation suites for families of graphics processors and memory chips.

·         Wrote and edited design and engineering specifications,

·         Wrote and edited technical reference manuals, programmer's reference guide, product brochures and bulletins, data sheets and application notes

·         Instituted firm's first document tracking

INTEL                                                                                                                                               SUNNYVALE, CA

Technical Writer......................................................................................................................................... 1997-1998

·         Updated data- and application books for the entire family of graphics processors, as part of Intel's Portable Graphics Group

·         Worked with supervisor to reorganize entire documentation format, structure and system

·         Wrote test procedure documentation, edited software release notes and produced ancillary training materials

·         Represented Intel at VESA standards meetings

BRESSLER COMPUTING                                                                                                                      OAKLAND, CA

Temporary Technical Writer................................................................................................................................. 1997

·         Authored and maintained web site on Sun Solaris system in Notepad, emacs and pico

·         Produced more than half the design, writing, editing and illustration in both the on-line help

·         Produced more than half the printed user's guide for EZaccess

·         Shared in the generous bonus for meeting an extremely aggressive deadline

BAYER BIOTECHNOLOGY                                                                                                                EMERYVILLE, CA

Validation Consultant................................................................................................................................... 1996-1997

·         Tested, documented and validated the software implementation of Building Automation System and Distributed Control System for cGMP/cGLP compliance

·         Wrote batch production records, standard operating procedures and training records

SYNERGYSTIC COMMUNICATIONS                                                                                                 SAN MATEO, CA

Temporary Technical Writer................................................................................................................................. 1995

·         FrameMaker editor on the 100,000-page set of end-user training manuals for the State of Florida

SIMPLY INTERNET                                                                                                                               SAN JOSE, CA

Temporary Technical Writer................................................................................................................................. 1995

·         Wrote and edited substantial portions of the first Internet Yellow Book (shovelware, to be honest)

·         Promoted from the team of 140 technical writers

·         Received cash awards for both volume and quality of contributions

SHAMAN PHARMACEUTICALS                                                                                       SOUTH SAN FRANCISCO, CA

Associate Scientist....................................................................................................................................... 1992-1994

·         Wrote analytical procedures for clinical drug trials

·         Worked with manufacturing, virology and ethnobotany departments to develop quality assurance protocols and documentation for FDA-regulated procedures

·         Developed and wrote analytical standard operating procedures for cGMP/cGLP environment

·         Wrote and edited training protocols, materials and records

·         Received award for discovery and documentation of a production process failure, which led to development of a more efficient process

·         Received awards for creating new product names

·         Promoted from Scientific Assistant in 1992 (Shaman Pharmaceuticals is now Shaman Botanicals)

CHIRON CORPORATION                                                                                                                 EMERYVILLE, CA

Methods Development Specialist................................................................................................................... 1987-1991

·         Refined, wrote and validated analytical methods for cGMP compliance

·         Helped elucidate relationship between glycosylation and activity, an important step in process development and clinical design

·         Developed and wrote analytical standard operating procedures for cGMP/cGLP environment

·         Wrote interim stability reports used to evaluate product performance and guide development decisions

DEY LABORATORIES                                                                                                                           CONCORD, CA

Product Development Chemist...................................................................................................................... 1982-1987

·         Developed new drug formulations for single-use aerosolized inhalants (and the odd topical product)

·         Designed and validated analytical methods for cGMP compliance

·         Developed the first single-dose sulfite-free isoetharine HCl formulation in the US

·         Developed and wrote analytical standard operating procedures for cGMP/cGLP environment

·         Wrote interim stability reports used to evaluate product performance and guide development decisions

 

 

EDUCATION

 

CALIFORNIA STATE UNIVERSITY, Chico and Hayward--Bachelor's in Chemistry

Additional classwork in UNIX system administration, Java for Android development, C#/.NET for Windows and
software QA for 21CFR Part8xx, Medical Devices  

 

Rev. 2017A1