Change Control Systems Specialist

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. As a Change Control Systems Specialist, you will process change control requests to ensure that process and documentation changes with the potential to impact the safety, purity, potency, and quality of manufactured product are thoroughly reviewed, justified, documented, approved, and implemented in conformance with regulatory requirements and company policies/procedures.

Requirements

• Ensure compliance with FDA regulations and all policies, guidelines, and SOPs related to change control.
• Process change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and plasma operations.
• Track and maintain change control request documentation throughout its lifecycle.
• Communicate with other departments and stakeholders to ensure efficient flow of change requests and information.
• Perform final review of change requests and its documentation to ensure completeness.

Benefits

• Medical
• Dental
• Vision
• PTO
• 401(K) match
• Tuition reimbursement