Under guidance of the RAQA Director, the Document Control & Training Specialist maintains the company quality management system in compliance with federal and international regulations as well as ensures companywide training is up to date.
Essential Job Functions:
- Manage release and control of updates to policies, procedures, instructions, etc.
- Manage, maintain process and distribute controlled documents and records in compliance with applicable regulations and company procedures
- Process all change orders for new and revised documents
- Create or revise documents in support of system, product or process changes
- Gather and prepare data for QA/RA meetings
- Assist with internal/external audits, CAPA’s and other QA/RA tasks
- Partners with managers and supervisors to ensure all training is completed timely and accurately
- Responsible for maintaining all employee training records
- Responsible for keeping KORU training matrix up to date
- Responsible for new employee on-board training
- High School degree or higher. At least 1-year experience in document control in the medical device or pharma industry preferred.
- Strong background with Microsoft Office: Word, Excel, PowerPoint; certificate preferred.
- Demonstrated ability with Microsoft Windows folder management
- Ability to take direction and multi-task in a fast-paced manufacturing environment
- Ability to work independently as well as in a team-oriented environment
- Strong communications skills
- Extremely detailed and organized
- Track record that demonstrates personal initiative and process development
Job Type: Full-time
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