About the Role
This position is responsible for maintaining procedures to ensure compliance with regulatory requirements.
The ideal candidate will have experience in quality control and assurance, as well as excellent communication and problem-solving skills.
Key Responsibilities:
1. Maintain procedures for document control activities to ensure compliance with cGMP, FDA, MDR and ISO requirements
2. Ensure site compliance with operating standards and regulatory requirements for documentation practices
3. Provide guidance on proper use of document management systems
4. Manage electronic change control system, doc control and record retention
5. Control changes to documented procedures, coordinate review and revision of controlled documents
6. Develop tools and resources to improve document quality and writing skills
7. Serve as System Administrator for doc control and learning management systems
8. Provide training and support for change control system users
9. Conduct internal audits and serve as auditor
10. Collaborate with management to assess and adjust programs and processes
11. Prepare reports for management
Requirements
* Experience in quality control and assurance
* Excellent communication and problem-solving skills
* Ability to work independently and collaboratively
* Proficiency in document management systems
Benefits
This role offers a competitive salary and benefits package, including medical, dental, and vision coverage, 401(k) matching, and paid time off.