Quality Assurance Specialist

Job Summary

To ensure compliance with GxP guidelines and support quality management systems, the full-time Quality Assurance Specialist will manage eQMS activities, facilitate audits, and analyze quality data while working in a hybrid environment.

Key responsibilities

• Maintain compliance with GxP guidelines and manage eQMS activities, including Deviations and CAPAs
• Support client audits and regulatory inspections, coordinating logistics and managing audit responses
• Analyze quality data to identify areas for improvement and generate reports on quality activities

Required qualifications

• Bachelor's degree or relevant work experience
• Minimum 2 years of experience in a Quality Assurance role
• Experience with GxP Quality Management Systems and handling Deviations, Quality Events, and CAPAs
• Preferred experience in Medical Information QA and assessing telephone calls in a call center
• Proficient in Microsoft Office Suite