JOB SUMMARY
Ensures documents meet established formatting standards and manages implementation activities in the Document Management System. Completes record activities including issuing, reconciling, scanning, and archiving. Provides oversight and support of document and records management activities. Conducts process and personnel training. Provides support during internal audits and regulatory inspections.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Document Control Support
• Ensure documents meet established formatting standards
• Manage implementation activities of documents, including lifecycle states in the Document Management System, user notifications, and issuance & reconciliation of controlled copies
• Complete record activities including issuing, reconciling, scanning, and archiving
• Troubleshoot and provide support for internal customers with technical questions related to Document Control processes and IT applications
• Participate in routine audits of Document Control processes and provide recommendations for improvement
• Represent the Document Control department on site projects
• Process access requests for Document Control IT applications
• Develop and conduct new Document Control employee training on operational procedures
• Conduct entry-level site training for Document Control processes and provide input on new and revised training content
Quality System Support
• Author and execute tasks for document revisions, deviation investigations, CAPAs, and change controls related to Document Control processes
• Compile and report performance metrics and data supporting Document Control processes
Continuous Improvement
• Identify opportunities for improvement within scope of work
• Coordinate and lead department 6S activities
• Educate department personnel on lean concepts
Regulatory Inspections
• Provide logistical support and technical knowledge during internal audits and regulatory inspections of Emergent quality systems
• Participate on response teams to address observations and recommendations made during internal audits and inspections
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education
• High school diploma
Experience
• 2-4 years working with an electronic Document Management System
• 2-4 years working within a regulated industry (at least 1 year of working in an FDA regulated industry preferred)
Knowledge
• Moderate understanding of regulations governing document and records management
• Basic understanding of deviation investigation, root cause analysis, CAPA, and change control systems
Skills
• Strong computer skills with the Microsoft Office product line
Abilities
• Ability to work individually and in a team environment with minimal supervision
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations