Job Summary
The Change Systems Analyst/Supervisor oversees change control systems and team activities, supporting compliance with GMP, ISO, and FDA requirements. The role owns the SAP system, creates training resources, and works with cross-functional partners to strengthen document-related processes.
Responsibilities
- Manage change control systems and supervise personnel to support compliant, effective operations.
- Maintain ownership of the SAP system used for change control.
- Develop training materials for relevant systems and processes.
- Partner across departments to improve document-related workflows and processes.
- Help ensure activities align with applicable GMP, ISO, and FDA regulations.
Qualifications
- Bachelor’s degree.
- At least 8 years of experience in operations, quality, or R&D, with a focus on electronic change control systems.
- Proficiency with SAP and Microsoft Office.
- Knowledge of quality standards and requirements in the medical device industry.
