The Role of the Clinical Quality Assurance Auditor

 By Robin Brodrick


The Clinical QA Auditor

Clinical Quality Assurance (QA) Auditors examine elements of clinical research and development (CR&D) trial activities. They may also participate in site selection, vendor qualification, GCP training for monitors, and the management of standard operating procedures (SOPs).

Traits of Amazing QA Auditors

Successful QA Auditors possess detective-like analytical skills and the ability to influence people over whom they have no authority. Those who are detail oriented but can still see the big picture will excel in the role. Most companies also look for candidates who have GCP knowledge, a bachelor’s degree in a relevant field, and audit certification.

Quality Assurance in a CRO

A contract research organization (CRO) has the unique ability to expose QA Auditors to a broad range of therapeutic areas. QA professionals may conduct internal, external, domestic, and foreign audits. The life of a QA Auditor in a CRO is very fast paced and there is little room for boredom.

Quality vs. Compliance - The Future of QA in Pharma & Biotech

Regulatory compliance does not always guarantee a quality product. According to FDA Commissioner Margaret Hamburg, M.D., the FDA is shifting its focus by pushing the industry to look beyond compliance and to strive for quality. This change will require an industry-wide evolution from the current reactive mode to a proactive mode. As a result, a true clinical quality professional will know the overall quality management system (QMS) and mentor the business to take ownership and build quality from the start of each project.

Are you a GCP Quality Assurance Auditor in MA? Send your resume to!