BUBobbie User
@bobbieuser
Experienced technical writer and document control specialist focused on regulated environments.
United StatesWhat I'm looking for
I am a technical writer and document control specialist with extensive experience managing Electronic Document Management Systems (EDMS) and authoring GxP-compliant documentation across pharmaceutical and healthcare environments.
I have executed documentation lifecycles in Veeva Vault, MasterControl, and Documentum (D2), authored SOPs, forms, training modules, and led quality documentation efforts supporting regulatory inspections and product development.
My roles have included coordinating multilingual document translation, creating Document Change Controls (DCCs), administering training programs, and producing metrics to support management decisions.
I excel at consolidating high volumes of technical information into clear, standardized templates and delivering high-quality documentation under tight deadlines while adapting quickly to new tools and processes.
Experience
Work history, roles, and key accomplishments
HIStreamlined Health Information Interoperability processes by eliciting team procedures, creating standardized templates, and consolidating high volumes of technical content to ensure quality, consistent style, and actionable execution plans.
AIAuthored and edited complex pharmacovigilance documentation (SOPs, protocols, forms, exams) and managed document lifecycles in Veeva Vault, coordinating stakeholder reviews, metadata, DCCs, and multilingual translations across 20+ languages.
Document Management Specialist
Mel Wolfe CPA, LLC
Oct 2020 - Aug 2021 (10 months)
Managed the firm's Document Management System and sensitive client records, prepared bound client reports, developed training manuals, supported CPAs with tax documentation, and diagnosed DMS/Lacerte issues.
QA Documentation & Training Lead
NX Development Corp.
Nov 2018 - Jul 2020 (1 year 8 months)
Served as EDMS SME (MasterControl) and led GxP documentation and training programs, managed quality systems and metrics, supported regulatory inspections, and participated in cross-functional project teams for product and clinical initiatives.
Quality Documentation Lead
US WorldMeds LLC
Feb 2016 - Nov 2018 (2 years 9 months)
Managed EDMS (Documentum D2/MasterControl) and maintained GxP documentation including change controls, CAPAs, deviations, audits, and training programs while providing monthly quality metrics and regulatory inspection support.
Document Control Specialist
Alchemy Aromatics LLC
Mar 2015 - Feb 2016 (11 months)
Developed and formatted company-wide SOPs, policies, and tracking tools; enforced CFR/cGMP documentation standards, audited production and QC records, and delivered training on SDS/GHS and safety compliance.
Account Services Specialist
Indatus Corp.
Nov 2014 - Mar 2015 (4 months)
Managed Call Tracker program, handled customer account provisioning and billing support, maintained audit records and contracts, and produced metrics and account documentation for support operations.
Assistant Production Manager
Kentuckiana Court Reporters LLC
Jun 2013 - Nov 2014 (1 year 5 months)
Transcribed legal depositions, managed transcript production, trained staff on software/equipment, authored equipment and production manuals, and served as a commissioned notary in KY and IN.
Education
Degrees, certifications, and relevant coursework
ICIvy Tech Community College
Associate of Science, General Studies
Completed an Associate of Science in General Studies at Ivy Tech Community College, conferred June 2016.
Availability
Location
United StatesAuthorized to work in
Job categories
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