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Technical Writer Manager

Location:
San Diego, California, United States
Posted:
December 11, 2018

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Resume:

Experienced Technical Writer/Editor Skilled in Creating Content for Semi-Conductor & Biotechnology/Pharmaceutical Industries

• Verbal and written communication skills, time management and well-organized, detailed, and quick learner, and works independently or in a team environment, work with SMEs, Program Management, QA

• Microsoft Office Products, Visio, Adobe Acrobat, Illustrator, Photoshop, FrameMaker, TechSmith Camtasia, Snipping Tool, SnagIt, Inkscape, Wiki (HTML), SharePoint, Perforce, Salesforce (DCRs), JIRA (Kanban boards), Confluence, tools written in Visual Basic, JavaScript

• Quality Events (QE): Deviations/Issues/Corrective Action and Preventive Action (CAPA)/Action Items/Periodic Reviews (PRs), ELISA Assay Kits, FDA guidelines, GxP, Product Development Process (PDP)

• Version control/document tracking systems: MasterControl 9.1, Content Management System (CCMS) using SDL LiveContent Architect Publication Manager and XMetal (XML using DITA standards), vTrack database, Agile, SAP

• Standard Operating Procedures (SOPs), QuickStart Guides, User Guides, Chipset Masters, Release Notes, Test Results, Application Notes, Technical Memos, Assay Hand-off Package, Verification & Validation Protocol/Plan, Design Input Document, Design Traceability Matrix (DTM)

PROFESSIONAL EXPERIENCE

Technical Writer (Contract), MLS Technologies/Illumina, San Diego, CA (Apr 2018 – Present)

Work with Quality, Program Management, R&D, Marketing, Software and Scientist SMEs, SW Dev team, and New Product Information teams to support and edit technical documentation for a variety of scientific audiences including Quality/Regulatory, Genomic Researchers, and lab technicians

Lead meetings to implement document changes from SMEs during weekly meetings (Confluence, BlueJeans, Jabber)

Generate documents that meet appropriate quality standard that adheres to ISO and FDA standards, adhering to best practices and departmental standards for terminology

Execute on SAP or other ERP systems processing of final documents finished documentation

Apply new collaborative tools, processes, and standards (Confluence, JIRA, internal tools, e.g., internal online tools via Confluence web pages)

Support Product Development Process (PDP) and generating documents, as needed in each phase from Concept to Commercialization

Engineering Technical Writer, Pacira Pharmaceuticals, San Diego, CA (Nov 2016 – Apr 2018)

Managed SOP documentation (including graphs, images, forms) through the eDMS (Master Control) lifecycle for Facilities, Engineering, and Manufacturing documentation (Validation Reports (BMS), Master Batch Records (MBRs), Operational and Preventive Maintenance SOP’s, Engineering Specifications) in collaboration with Quality, Microbiology, Manufacturing, Regulatory, Supply Ops, Validation, Security, Project Managers, Facilities, and Calibration, Electrical, and Hardware Engineers

Prepared weekly status updates on SOP and Quality Events (QE) progress and review Daily Rounds for audit compliance

Consolidated/evaluated deviations and issues as a technical reviewer/author based on supplied information from collaborators and review/edit Investigations

Assisted with Building 6 Decommissioning Project and build Preventive Maintenance: Steris AMSCO Lab 250 Autoclave (2AH-01) & Preventive Maintenance: Reliance 500XLS Laboratory Glassware Washer Review and consolidate project specifications and project submittals in support of building Engineering Library of Site specifications using SharePoint

Participated in MasterControl Super User meetings and test and provide feedback on improvements on the upcoming roll out of Master Control 11.6

Trained on Principles of Aseptic Processing, GxP 4-hour annual refresher: GxP Orientation Program, Regulatory Audits, Building a Culture of Quality and Compliance, and Basics of Good Documentation Practices (data integrity)

Associate Technical Writer (Contract), IPS America/Thermo Fisher Scientific (Life Technologies), Carlsbad (Nov 2015 – Nov 2016)

Set up and updated topics via check out/check in for ELISA Assay Kits (Legacy Life Tech, Luminex, and Pierce) based on product manuals and existing content stored in CCMS using SDL LiveContent Architect Publication Manager and XMetal (XML using DITA standards) in rebranding efforts for Life Sciences>Protein Biology

Copied content from Word or PDF and pasted into XMetaL, tagged elements according to content type, as well as updated content in v_reuse variable file, which contained variable definitions for content reuse and standardization efforts

Rendered screen shots with SnagIt and redrew graphics using Inkscape

Tested and provided feedback using Acrolinx plug-in within XMetal topics

Handled product manual reviews (via FileXchange), redlines and approvals, provided packaged files (readmefirst.doc, web, print, redlines, and original PDFs) for Agile DCOs (i.e., released DHF objects)

Published and released ELISA product information sheets under tight deadlines with exceptional attention to detail and very high degree of accuracy

Sr. Technical Writer, Qualcomm, Inc., San Diego (Jul 2005 – Nov 2015)

Provided software documentation support (test procedures/results, user guides, release notes, technical memos, and applications notes) while applying editing standards and procedures and style sheets for documentation ranging from Word, PowerPoint (including audio and video), Excel, and FrameMaker, Perforce, Camtasia, Agile ECOs (released DMR objects, i.e., Parts and Documents)

Redrew drawings, sketches, diagrams, and charts using Microsoft Visio, Adobe Illustrator/Photoshop

Updated and maintained department templates with implementation and integration of macros for efficiency in documentation processing, lead for internal tool testing

Demonstrated multi-tasking exposure in various projects that included updates to Wiki (HTML)/SharePoint pages with content as needed to support multidisciplinary teams and solved DCRs/customer problems related to documentation in Salesforce, document translations (Chinese), and ran queries to generate Agile reports in Excel

Wrote and maintained job aid materials, as well as provided training and peer reviews to new and temporary employees, including domestic and international offices

EDUCATION

BS, Business Administration, University of Redlands, Redlands, CA

Coursework, Graphic Communications, Palomar College, San Marcos, CA

Certificate, Computer Information Science, Coleman College, San Diego, CA

Certificate, Technical Communications, UCSD Extension Studies,

San Diego, CA (completion: 2020)

PROFESSIONAL DEVELOPMENT

Business Writing Fundamentals, Lynda.com

Grammar Fundamentals, Lynda.com

Copyediting I and Grammar Lab, UCSD Extension Studies

Good Manufacturing Practice (GMP), ispe.org

International Society for Pharmaceutical Engineering (ISPE)

Society for Technical Communication (STC)



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