Quality Assurance Specialist - Document Control

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.