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.
Werfen provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
