Change Control Coordinator

Develops and manages the Change Control (CC) process and supports the Document Control process. Works with Global Quality, Compliance, Validation, Global Sources and Suppliers,and Engineering to develop standards and criteria required for change control, qualification of change, and requalification of equipment and re-validation of processes when required by change.

• Ensure consistent quality of GOJO products through standardized procedures, processes, materials, and equipment.
• Maintain cGMP compliance with cosmetic and drug regulations.
• Optimize processes for cost, quality, and efficiency through whole systems design and continuous improvement.
• Conduct initial reviews to assess the need for Change Control and its impact on systems and operations.
• Manage a Change Control program to keep production facilities, equipment, IT systems, and supporting systems qualified.
• Develop and coordinate standards for change control, including criteria and methodology for qualifying changes.
• Standardize and classify types of changes related to validated systems and processes.
• Review paperwork for completeness and accuracy; train and assist change requestors/reviewers.
• Distribute and collect change control request forms, compile assessments, and coordinate with QA for final approval.
• Compile supporting documentation for Change Control closure and coordinate with QA.
• Follow up with change owners to ensure controls are on track.
• Communicate change control approval status and requirements to relevant parties.
• Support document management and retention policies.
• Maintain an up-to-date change control database to track progress and meet regulatory and customer requirements.
• Serve as primary support for the Documentation Control Department when needed.
• Administer and coordinate a standardized change control program to ensure GMP compliance.
• Review change controls for FDA compliance and make reliable decisions on handling changes.
• Maintain accurate and current change control documentation and train personnel.
• Revise and maintain change control databases.
• Continuously improve the efficiency and compliance of change control systems.
• Create and publish internal department and company-wide quality metrics related to Change Control.
• Ensure successful and timely completion of projects and assignments.
• Communicate effectively and accurately with team members, other departments, and outside vendors/associations.

* High School Diploma or Equivalent

* MS Office experience in Word and Excel preferred

May coordinate problem-solving teams to address process issues.