Document Control Supervisor
Supervisor, Incoming Document Control is responsible for the management of the document control process and controlled documents. Assist employees with recommendations regarding the release, structure and change of all controlled documentation.
- Manages the Document Control team including setting daily priorities; provides feedback to management on individual performance; ensures Document Control personnel have trained to required procedures
- Responsible for ensuring proper validation performed for the document management system (new software systems, updates, changes to workflows, etc.)
- Responsible for the development and maintenance of document templates
- Responsible for ensuring the document approval matrix is updated as needed
- Ensures annual reviews of controlled documents are performed as required
- Ensures maintenance of a computer database of all filed documentation that ensures fast retrieval of documents via company intranet website
- Ensures that historical files for Design History File (DHF), Device Master Records (DMR), Device History Records (DHR), Design Review, Validations, SOP’s, and other quality system documents are maintained.
- Manage archival activities for controlled documents and validation files to meet requirements of CLIA/CAP, QSR 820, ISO 13485, and State Standards.
- Assists with the maintenance of company training records.
- Performs duties of Document Control Coordinator as needed
- Other duties as assigned
- Bachelor’s degree or equivalent
- 3 plus years’ experience with electronic document management systems
- 2 plus years of supervising teams
- Experience in a regulated environment (CLIA, FDA, ISO)
Knowledge, Skills, and Abilities:
- Computer skills (MS Word, Excel, PowerPoint, etc.)
- Good writing and communication skills
- Independent worker, a self-starter with strong organizational and planning skills
- Ability to work with others, manage small projects, mentor others
- Knowledge of CLIA, FDA, and/or ISO 13485 Good Documentation practices