Change Control Administrator bei None

Job Summary:

The Change Control Administrator provides administrative support for the change control process within the Quality Management System (QMS). In this role, the Administrator ensures that all changes are properly logged, documented, and tracked to meet internal procedures and regulatory expectations. Working closely with the Change Control Manager and cross-functional teams, this position helps maintain audit-ready records, and monitors timelines.   The below is intended to describe the general content of and requirements for the performance of this job and is not to be construed as an exhaustive statement of essential functions, responsibilities, or requirements.

Primary Duties and Responsibilities

1. Log, track, and monitor change requests in the Quality Management System (QMS), ensuring accuracy and compliance with established procedures.
2. Review requests for completeness and clarity prior to routing for appropriate review and approval, minimizing delays in the change process.
3. Maintain organized and audit ready records for all change controls, supporting compliance with applicable requirements.
4. Monitor timelines, overdue items, and other performance metrics; prepare summary reports to highlight trends
5. Support audit and inspection activities by coordinating, retrieving and presenting change control documentation as needed
6. Collaborate with cross functional teams to answer questions, provide guidance on submission requirements, and ensure consistent application of the change control process.
7. Regular and reliable attendance expected
8. Other work-related duties as assigned by supervisor/manager

Minimum Knowledge, Abilities, and Skills Required

1. A Bachelor's Degree in Business Administration, Science, Communications or related field.  
2. Strong attention to detail, organizational skills and ability to manage multiple priorities.
3. Excellent communication skills, both written and verbal.
4. Strong analytical and problem-solving skills.
5. Knowledge of office administrative procedures.
6. Proficient in relevant software applications such as Microsoft Office (Word, Excel, PowerPoint) or similar tools for reporting and data analysis.