Quality Specialist I

Job Summary

Assisting Quality Management in monitoring GCP regulatory compliance, the full-time remote Quality Specialist I will schedule and perform internal assessments, manage quality metrics, and support continuous improvement initiatives in clinical trial operational activities.

Key responsibilities

• Schedule and conduct internal assessments, including audits and equipment validations
• Update and maintain quality metrics and Key Performance Indicators for management review
• Participate in root cause analyses and track non-conformance reporting and corrective actions

Required qualifications

• Bachelor's degree (B.S./B.A.) preferred
• 1-2 years of related experience and/or training, or equivalent combination of education and experience
• Experience with quality management systems and regulatory compliance in clinical trials
• Ability to work independently and collaboratively on multiple projects
• Familiarity with document control and record retention requirements