Change Control Systems Specialist

Responsibilities

• Processes change control requests to ensure that process and documentation changes are thoroughly reviewed, justified, documented, and implemented in conformance with regulatory requirements.
• Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change control.
• Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and operations.
• Tracks and maintains change control request documentation throughout its lifecycle: creation/revision, review and approval, implementation, closure.
• Coordinates change control process to ensure timely delivery of change requests and information to customers.
• Communicates with other departments to ensure efficient flow of change requests.
• Prepares changes for review and engages leadership and subject matter experts as needed.

• Bachelor's degree in a scientific field.
• Typically requires 5 years of related experience.
• Strong knowledge of Food and Drug Administration (FDA) regulatory requirements for good manufacturing practices.
• Demonstrated spreadsheet and database computer software skills.
• Excellent oral and written communication skills.
• Strong problem solving skills.
• Attention to detail.
• Ability to prioritize and work independently with limited supervision.

Demonstrates expertise in managing change control processes in compliance with FDA regulations and cGMP manufacturing practices. Proficient in documentation management, communication across departments, and problem‑solving with a strong attention to detail.