Document Control/Training Specialist II
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.
Principal Duties and Responsibilities include the following:
(Other duties may be assigned)
- eDMS administration
- Responsible 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.
- Assess document packets in eDMS to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, training plan, etc.
- Create or update training course and exams within MasterControl associated with new and revising documents.
- Support document archive program.
- Maintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed.
- Maintain appropriate chain of custody for controlled documents submitted for archival.
- Scanning of quality systems documentation prior to archival.
- Maintain archive database for accuracy of documentation details and location.
- Retrieval of documentation upon internal customer request and during inspection activities.
- Prepare and coordinate documentation transfer to offsite archive.
- Support and advise end users on document system requirements and workflows.
- Evaluate 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
- Identify opportunities for process and system improvement and enhancement
- Participate in quality and process improvement initiatives and project teams.
- Provide support for internal/external audits and inspections.
- Contribute to deviation investigations and CAPAs within scope.
- 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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