Quality Assurance Specialist - Document Control

Location: Boston Consulting

Job Description

Essential Duties and Responsibilities:

  • Manage document control program and workflows in both paper-based system and electronic Document Management System (eDMS) to ensure documents are managed through the controlled document lifecycle in accordance with established procedures
  • Coordinate cross-functional reviews and approvals to meet project timelines
  • Provide end user training on eDMS and other systems within the scope of job responsibilities
  • Create and modify user accounts and administer training program in eDMS according to established procedures
  • Compile metrics for document control to identify areas for quality system improvements
  • Ensure documents meet formatting and template requirements
  • Issue GxP documents and labels
  • Maintain and organize GxP documentation in high density filing room and manage GxP documentation tracking, reconciliation, and archival
  • Provide documentation support during client audits and regulatory inspections
  • Author or revise SOPs related to document control, as needed
  • Generate and distribute meeting minutes for routine quality system meetings
  • Assists with the improvement of quality compliance by identifying recurring issues and trends
  • Manage incoming requests to QA department by resolving independently or elevating to senior QA personnel
  • BS in Engineering, Science or equivalent technical degree.
  • A minimum of 2 years of experience in Quality Assurance or related field
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Experience with eDMS system and GxP documentation
  • Proficient in Microsoft Word, Excel, and PowerPoint.


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