Quality Assurance Specialist

Job Summary

Seeking a dedicated Quality Assurance Specialist (GxP) to work remotely, this full-time position will manage quality and compliance for clinical trials, ensuring adherence to SOPs, GCP, and FDA/ICH guidelines while supporting audit functions and quality initiatives.

Key responsibilities

• Conduct regular quality assurance reviews and ensure compliance with Standard Operating Procedures at clinical research sites
• Execute the yearly corporate audit plan, tracking audits and preparing detailed outcome reports for management
• Collaborate with research staff to resolve compliance issues and develop Corrective and Preventative Action (CAPA) plans

Required qualifications

• Bachelor's degree in a relevant field
• Minimum of 2 years of experience in Quality Assurance and 4 years in Clinical Research in a compliance or GCP role
• Fluency in Portuguese and English; Spanish is a plus
• Strong knowledge of federal regulations and Good Clinical Practices (GCP)
• Experience with internal and external audits, including FDA and GCP compliance