Quality Operations Specialist I

The QRC Specialist will support operational Quality Risk and Compliance (QRC) activities within Research & Development (R&D). The role focuses on inspection readiness, quality metrics, process improvements, and cross-functional coordination. The ideal candidate will collaborate closely with departments including Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs.

• Track and close inspection readiness action items across multiple workstreams

• Schedule meetings, trainings, and document meeting minutes

• Maintain and update SME lists (GCP, GVP, GMP) for inspections

• Support CAPA follow-up and document lessons learned from mock inspections

• Follow up with study teams on metrics and spot check responses

• Monitor training completion using Power BI compliance metrics

• Pull raw data from systems for metrics and reports

• Assist with process improvement program tracking

• Monitor QRC budgets and invoice follow-ups

• Track controlled documents and coordinate training curriculum changes

• Support training workshop logistics and general meeting coordination

• Take minutes and follow up on action items as needed

Education:

• Bachelor’s degree in Science or related field

Required Skills:

• Strong verbal and written communication

• Ability to work independently and within cross-functional teams

• Highly organized with strong follow-up and multitasking capabilities

• Proficient in Microsoft Office Suite (Word, PowerPoint, Excel)

• Experience with Power BI is a plus

• Strong interpersonal and problem-solving skills