CMSU Research Packaging Coordinator III

About Rochester

As a community, the University of Rochester is defined by a deep commitment to Meliora – Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Summary

This position requires an advanced understanding of current Good Manufacturing Practices (cGMP) as defined in 21 CFR FDA regulations and applies those to the procurement, handling, inspection, storage, and processing of clinical trials supplies within the Clinical Materials Services Unit.

Key Responsibilities

• Work independently with minimal guidance in generating SOPs, Process Orders, and CMSS documents.
• Participate in client team meetings and ensure CMSU deliverables are completed per agreed timelines.
• Participate in regulatory inspections and external audits.
• Function as a backup to the Facility Coordinator and manage various aspects of the facility.
• Deliver training programs and assume supervisory responsibilities as needed.
• Follow GMPs and high-quality standards in the labeling of clinical materials according to written procedures.
• Provide feedback for improvements in existing systems and procedures.
• Execute I/O/PQ and Production Validation Protocols for packaging equipment.

Requirements

• Advanced understanding of cGMP.
• Strong critical thinking skills.