• Document Control/Training Specialist

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(11/1/2018 8:31 AM)
    Job ID
    2018-1151
    # of Openings
    1
    Category
    Quality
  • Overview

    The Document Control / Training Specialist supports all activities within the Document Control and Training team, including administering the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, archival, customer support, establishment of training courses within the eDMS, and logbook and data collection form control.

    Responsibilities

    •eDMS administration
    oResponsible for ensuring the administration of the eDMS system (MasterControl), including working with the provider to troubleshoot system issues, improving and adding workflows as required, creating new document types and templates, generating and performing user training, setting up and generating reports/ad-hoc reports, and supporting with upgrades/expanded use the eDMS tool into an eQMS. 'Championing’ the use of the eDMS and engaging with the user community to identify continual improvement opportunities
    •Quality documentation processing in support of ongoing projects and daily GxP operations
    oAssess document packets in eDMS to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, training plan, etc.
    oCreate or update training course and exams within MasterControl associated with new and revising documents
    •Support document archive program
    oMaintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed
    oMaintain appropriate chain of custody for controlled documents submitted for archival
    oScanning of quality systems documentation prior to archival
    oMaintain archive database for accuracy of documentation details and location
    oRetrieval of documentation upon internal customer request and during inspection activities
    oPrepare and coordinate documentation transfer to offsite archive
    •Support and advise end users on document system requirements and workflows
    oEvaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to manager as appropriate
    •Support with enhancement to documentation control processes and systems
    oIdentify opportunities for process and system improvement and enhancement
    oParticipate in quality and process improvement initiatives and project teams
    oProvide support for internal/external audits and inspections
    oContribute to deviation investigations and CAPAs within scope

    Qualifications

    •Bachelor’s degree or equivalent
    •Minimum of 3 years previous experience in document management in a GxP environment, and minimum of 5 years working in a GMP environment
    •Proficiency with MS Office, including Word
    •Experience with MasterControl or other electronic documentation and training management system

    •Strong organizational and/or project management skills
    •Solid written and verbal communication skills, experience with technical writing a plus
    •Sound communication skills and customer focus, with ability to interact in a cross functional organization

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