Clinical Quality Assurance Associate

Job Summary

A company is looking for a Clinical Quality Assurance Associate to support the management of GCP-related items within the Quality Management System across clinical activities.

Key Responsibilities

• Ensure GCP compliance and promote best practices across regulated activities
• Investigate deviations and complaints, and follow up on CAPAs for timely resolution
• Review clinical trial documents and eTMF for accuracy and completeness

Required Qualifications

• Bachelor's Degree or higher in pharmaceutical, life sciences, or engineering concentration
• 0-3 years of experience in a Quality-related role with exposure to GCP activities
• Familiarity with eTMFs and proficiency in Microsoft Office
• Knowledge of ICH GCP guidelines and relevant regulatory requirements
• Self-motivated and proactive with strong organizational skills