Resume

Sign in

Microsoft Office Technical Writer & QA Tester

Location:
Glastonbury, Connecticut, United States
Posted:
October 22, 2016

Contact this candidate

Nancy Lee Johnston

*** **** ******

Glastonbury, CT 06033

860-***-****

acw6pz@r.postjobfree.com

SUMMARY

As a scientist who likes to write, I have 15 years experience in writing, editing, and publications management; 2 years experience working on a Y2K Team within Software Quality Assurance; 5 years experience in a pharmaceutical software testing environment; 1 year in document management control; 1 year experience in a medical device software testing environment; and 2 years experience teaching college courses.

Developed an extensive knowledge of scientific and technical terminology combined with an ability to organize information in a logical and concise manner. Visualized concepts and related abstract ideas in both biotechnology and engineering fields.

Edited research papers at the doctoral level. Researched and clarified problems and located resources.

Managed publications from conception through final production. Developed skills in graphic arts and photography and in specifying printed materials. Assessed overall scope of the job and met deadlines.

Wrote patent applications and patent feasibility reports.

Interacted effectively with engineers, scientists, software engineers, and developers because of my excellent oral and written communications skills.

Learned new software quickly and then explained its use to the customer/end user.

Wrote software requirements, test scripts, and Use Cases employing testing tools. Analyzed test results and wrote Deviation Reports detailing discrepancies. Developed understanding of the entire software development life cycle (SDLC).

Industries

Pharmaceuticals & Specialty Chemicals, Biotechnology (laboratory & medical equipment manufacturers), Engineering (aircraft, filtration equipment), Academics (online university, college instructor), Healthcare (insurance), Government (State of Connecticut Department of Labor)

Functional Areas

Technical writing, QA testing, college instructor, training, document research, document management

SKILLS PROFILE

Databases / DB Tools: Lotus Notes, InSight, SourceForge, Agile v9.3, Sharepoint, firstDoc (customized Documentum)

Desktop Tools: Adobe Acrobat XI Pro, Microsoft Word, Excel, Powerpoint, Visio, Project, SnagIt

Methodologies / Techniques: iSLC (Pfizer-specific Informatics System Life Cycle templates)

Operating Systems: Microsoft Office 2010, 2013

Testing Tools: Quality Center/TestDirector, SQL Navigator

PROFESSIONAL EXPERIENCE

eTeam, Inc. – Contract Assignment 07/15 – 06/16

Alexion Pharmaceuticals, Inc.

Document Management Control

Converted 300 Standard Operating Procedures (SOPs) into a new Word template.

Proofed the documents for spelling, punctuation, and grammar.

Reformatted sections, tables, and figures.

Read the SOPs for continuity and accuracy. (I have a scientific background in biology and chemistry and I have also written many operating manuals for the equipment in the Alexion laboratory departments; because of this, I also reviewed the documents for technical accuracy, when possible.)

Checked all references to sources outside of Alexion via the web.

Analyzed and merged several SOPs from various sources into new SOPs.

Helped first-time users of the SOP template with formatting and overall presentation issues within the SOP.

Met with document control and with scientists from the Bioanalytical Laboratory Department when they needed to create a template for their Validation documents; these documents are to be added to the firstDoc document repository. Created the template for Validation documents with tables and charts that can be filled in for different pieces of equipment.

Met with Clinical department scientists when they first used the new SOP template. Converted the document and reformatted tables and figures. Pointed out technical inconsistencies that needed to be corrected when creating additional documents. Reformatted their existing tables so that they could be used as templates for future documentation.

Wrote an instruction manual for first-time users of the new SOP template. [The template was set up with lists within lists and, therefore, was not intuitive.]

Converted 250 Forms associated with the SOPs into a new Word template.

Converted 100 forms from Word into fillable Adobe Acrobat XI Pro forms.

Wrote an instruction manual for converting Alexion Word forms into Adobe Acrobat XI Pro forms.

Converted several Excel spreadsheets into fillable Abobe Acrobat XI Pro forms.

Reviewed Powerpoint presentations for accuracy and edited incorporated graphics and tables.

Created an Excel spreadsheet for a Glossary of Terms, Acronyms, and Abbreviations sourced from the SOPs and from several small existing Glossaries.

The newly compiled Glossary contains over 2,200 entries and is sortable and filterable by SOP designation, date, type of definition (e.g., abbreviation).

The Glossary has built-in instructions for optimal use. [Excel ‘Comments’ are used to create footnotes that can be printed out at the end of the Glossary.]

The Glossary is designed to provide Alexion with a useful tool for creating documentation. It can be a living document that should be updated periodically to reflect new terminology and to standardize terminology usage within the R&D departments.

Environment: Microsoft Office Suite, Sharepoint, firstDoc (customized Documentum)

SmartFolks, Inc. – Contract Assignment

05/14 – 11/14

Connecticut Department of Labor – Appeals Division

Deployment Lead

Wrote 2 user guides for the Appeals Scheduler application (proprietary software developed for manual and automated scheduling of unemployment hearings). These manuals target: hearing referees, support staff, system administrators, and IT administrators.

While creating the user guides, performed ad hoc testing of the software.

Logged software bugs in the CT-DOL bug-tracking system and verified bug correction.

Prepared discussion points with functional descriptions for deployment meetings with developers.

Contributed to the training curriculum and its implementation by writing 2 training manuals based on the user guides.

Environment: Microsoft Office, Sharepoint.

Kelly IT Services – Contract Assignment with Covidien

01/12 – 12/12

Surgical Solutions/ Medical Devices

Technical Writer + QA Tester

Wrote test scripts and updated requirements for Agile v9.3 software in a GxP/validated system under the supervision of the Principal Validation Engineer.

The test scripts depicted actual workflows and user security profile privileges.

Wrote Deviation Reports after analyzing QA test data.

Resolved discrepancies with input from Information Services and Validation.

Worked with QA testers during re-testing cycle.

Performed testing in the Agile v9.3 environment. [Agile v9.3 is Covidien’s manufacturing parts and documentation control and tracking software.]

Reconciled Operational Qualification (OQ) requirements in the Traceability Matrix.

Created and maintained functional requirements history in a Word document and an Excel spreadsheet.

Environment: Microsoft Office, Agile v9.3, SharePoint.

Keane, Inc. – Contract Assignments with Pfizer, Inc.

07/04 – 10/09

Pharmaceuticals

Technical Writer + QA Tester (CSDS)

Wrote requirements and test scripts for Pfizer's proprietary Clinical Supplies Distribution System (CSDS) in software Research Informatics (RI).

Reconciled requirements in Traceability Matrix for User Acceptance Tests (UATs).

Entered software bugs into SouceForge database so that developers could address functional and screen issues during software development.

Wrote Use Cases with Business Analyst during development phase.

Attended workshops with Business users to assess their needs.

Ran SQL scripts to search database for inventory and ran test scripts during OQ and Regression testing cycles.

Learned to use: Clinicopia (COTS) software that is used for drug packaging and supply; CSDS software as it was being developed for drug supply chain management; Impala software that is used for protocol administration and drug assignment; Quality Center (previously TestDirector) that is used for managing quality assurance requirements gathering, test script creation, and ad hoc software testing; and SQL Navigator that is used to run SQL scripts during database searches for testing inventory.

Last 2 years worked remotely 80% of the time (telecommuted).

Environment: InSight, Microsoft Office, Quality Center (previously TestDirector), Clinicopia, CSDS, Impala, SourceForge (software bug tracking system), SQL Navigator.

Technical Writer (Additional Projects)

Wrote documentation during the software development cycle using Informatics System Life Cycle (iSLC) process templates while supporting 3 Project Managers in Development Informatics (DEVi).

Wrote the User's Guide for the LabWare Laboratory Information Management System (LIMS) software and the Quick Reference Guide for LabWare to be used during training at the New Haven Clinical Research Unit (NHCRU).

Reviewed and formatted middleware test scripts for the Interface Engineer using Quovadx (healthcare) software.

Wrote test scripts for Impala system while working closely with developers in DEVi. [The Impala application controls drug assignment and drug inventory at clinical trial sites.]

Wrote end user guide for Dendrite, a group associated with the Protocol Administration Group (PAG).

During the writing process, also entered all software bugs encountered into SourceForge.

Learned to use: Impala software, InSight (document repository database), SourceForge, and DaTAMS (Documentation and Testing Association Management System developed in-house) that is used for creating Requirements documents and test scripts. DaTAMS has full tracking/auditing capabilities. All entries in DaTAMS are made using basic HTML code. Also learned to use iSLC document templates.

Environment: Impala Software, InSight, SourceForge, DaTAMS, Microsoft Office, iSLC.

07/01 – 06/04

Kaplan University closed its Belmont office. When I returned to Connecticut, my mother was diagnosed with a terminal illness and I remained in Connecticut to care for her.

Kaplan University

Online University

08/00 – 07/01

Technical Writer

Worked closely with software engineers and web developers as the online Kaplan University website moved from development, to staging, to production using the latest interactive web applications.

Wrote customer/end user documentation for Kaplan University software programs including those designed for Student Support Services and B2B customers.

Wrote the Faculty Resource Manual for the Dean of the Business School.

Reviewed all technical documentation for consistency and clarity from the customer’s standpoint.

Reviewed on-screen copy and provided content for end user instructions.

Wrote copy for the student and faculty messaging system.

Environment: Microsoft Office, proprietary software.

PerkinElmer

Analytical Device Manufacturer

6/98 – 4/00

Documentation & Y2K Testing Coordinator

Established standards for Y2K testing of analytical instruments and associated software.

Wrote Test Plan and created templates for test documentation and reports. The product lines tested included: atomic absorption, chromatography data systems, gas chromatography/mass spectroscopy, FTIR/dispersive spectroscopy, inductively-coupled plasma/optical emission spectroscopy, liquid chromatography, organic elemental analysis, thermal elemental analysis, and UV/Vis and fluorescence spectroscopy.

Reviewed all Y2K test reports and documentation from PerkinElmer’s worldwide operations.

Worked closely with product managers across product lines to assess which instruments and software required Y2K testing.

Guided SQA testers as they performed Y2K testing.

Conducted seminars for customer support personnel regarding Y2K issues.

Familiarized over 70 seminar participants with legal responsibilities (including Congress’ Readiness and Responsibility Act).

After approving Y2K test reports and documentation, issued Y2K Readiness Disclosures and created Excel spreadsheets identifying the Y2K compliance status for over 500 analytical instruments.

Worked closely with the legal department to ensure that the Y2K Readiness Disclosures and the product listings conformed to the stated PerkinElmer compliance.

Presented test documentation to the Gartner Group during an internal Y2K audit.

Submitted Y2K Readiness Disclosures and product listings (Excel spreadsheets) to the web designer for posting on the PerkinElmer website.

Also posted results in company-wide Lotus Notes databases while keeping the Software QA Manager apprised of testing statuses.

Environment: Lotus Notes database, Microsoft Office.

Cigna Corporation

Health Insurance

/97

Technical Writer

Prepared technical documentation during the product development phase of a new CIGNA HealthCare product. Assisted the Andersen Consultants in product management and workflow design.

Wrote detailed reports of Composition/Credentialing/Contracting meetings attended by subject matter experts from nationwide offices.

Created Powerpoint presentation materials for meeting facilitators.

Manchester Technical Community College

Academics

/97 – /98

Vocal Instructor

PRIOR EXPERIENCE

United Technologies Corporation

Engineering (Aircraft)

Technical Writing Consultant

Completed 3 training modules for airflow testing and 1 training module describing the use of an industrial grinding machine.

The airflow testing training modules described comprehensive test protocols for in-process and final inspection as well as detailed operating procedures for the test equipment.

These in-depth operating manuals are used to train and certify all operators on the shop floor in compliance with government regulations.

Learned to use computer-controlled robotics equipment designed for in-process and final inspection of aircraft engine blades and vanes so that I could write the training manuals.

Dorr-Oliver

Industrial Filtration

Technical Writing Consultant

Prepared 120 overhead transparencies using Powerpoint for the Sales & Marketing Division.

The presentation materials described all industrial separation products sold by Dorr-Oliver and included extensive supplementary notes to aid Sales & Marketing personnel during their presentations.

Alexion Pharmceuticals

Pharmaceuticals/Genetic Engineering

Technical Writing Consultant

Wrote the background of a patent application for a novel process to be used in gene-therapy applications.

Researched 21 journal articles and patent applications pertaining to endothelial cells.

Became familiar with genetic engineering principles.

Dorr-Oliver – Engineering

Technical Writing Contractor

Wrote 3 operating manuals (120 – 350 pages) for state-of-the-art high-pressure liquid chromatography (HPLC) systems. These systems are designed for the pharmaceutical industry and are used to separate the pure product. One system is operated manually and the other 2 systems are operated semi-automatically or under complete computer control. Learned to use the HPLC system with integrated instrumentation.

Provided operating instructions in each manual for:

installing the system, start-up, and priming

operating the control panels and menu selection (where automated)

understanding all alarms and error messages, and troubleshooting the system using the alarms and error messages.

Organized the supporting OEM documentation for the individual components and instruments used in the HPLC systems (including: pumps; valves; photodetectors; flow meters; chart recorders; pH, conductivity, and UV detectors; and the computer hardware and software).

Bio-Tek Instruments – Analytical & Medical Device Manufacturer /Technical Writer

Wrote all technical operators’ manuals.

The laboratory equipment included: microplate readers, washers, and stackers used for enzyme immunoassays (EIA), protein determinations, cytotoxicity, and cytoproliferation. The biomedical testing equipment included: defibrillator analyzers, electrical safety analyzers, ventilator testers, and laser power meters.

Designed marketing literature (e.g., a new handbook design for hand-held biomedical devices).

Researched and wrote a 350-page software manual (including 35 tables and 48 figures, some of which were detailed flowcharts).

The software was designed for use with automated microplate readers.

The software contained all testing criteria and parameters necessary for data reduction of absorbance values generated when using enzyme-linked immunosorbent assay (ELISA) tests. [Heterogeneous enzyme immunoassays are used for determination of antigens, antibodies, and proteins based on indirect, sandwich, and competitive assay principles.]

Prepared contractually-required quarterly design reports for the laboratory equipment manufacturer which had entered into a joint venture with a clinical chemicals manufacturer.

City Colleges Of Chicago – Academics / College Instructor & Registrar

Taught 2 semesters of Freshman Biology: Introduction to Biology & Laboratory.

Developed the laboratory portion of the course and ordered all supplies and equipment.

Taught 2 semesters of Freshman English: Composition & Grammar.

As Registrar, enrolled students at northern Germany sites.

Established the most extensive Emergency Medical Technician (EMT) curriculum in the European theater.

Kelco Division, Merck & Co., Inc. – Pharmaceutical & Specialty Chemicals / Technical Writer

Wrote all technical brochures and bulletins for the following product lines: pharmaceuticals, food, cosmetic, textile, paper, paint, oilfield, and industrial.

Wrote 4 patent applications and 2 in-depth patent feasibility reports.

Edited scientific journal articles, convention poster displays, formulations, oral presentations, safety manuals for plant personnel, 5-year plans for R&D, brochures for Commercial Development, and reports submitted to government agencies (e.g., the Bureau of Veterinary Medicine and the Environmental Protection Agency).

Coordinated all artwork and photography for technical presentations.

Budgeted and scheduled artwork with vendors. Established a computer-accessed artwork file.

Requested latest research information from university professors.

Introduced new developments in the field of rheology to R&D upper management.

Education

DEGREE NAME (BA)

English/Biology (Major) Chemistry (Minor)

University of Connecticut, Storrs, CT, USA

CERTIFICATE

Opera Performance

American Institute of Musical Studies (AIMS), Graz, Austria

Professional Affiliations

Society for Technical Communications (STC)

San Diego Chapter

Offices held: Coordinator, International Graphic Arts Competition; Chairman, Regional Technical Publications & Graphics Arts Competition; Secretary; Program Chairman.

One of 3 judges for the Regional Technical Publications Competition.

International Association of Business Communicators (IABC)

Government Security Clearance

Secret Security Clearance (No longer active)



Contact this candidate