Quality Assurance Auditor II — Compliance Advocate

IQVIA; Austin (TX); On-site; USD 54,000 - 135,000; Full time

Job summary

IQVIA Laboratories in Austin, TX is seeking a Quality Assurance Auditor 2 to join the Protein Biomarkers Quality Assurance team. This role focuses on internal audits, CAPA oversight, regulatory readiness, and quality system performance to support client audits and inspections.

The position requires a Bachelor’s degree with 3 years in a GxP-regulated QA environment, strong CAPA and audit experience, and working knowledge of GxP.

Qualifications

• Bachelor’s degree or equivalent combination of education, training, and relevant experience.
• 3 years of experience in Quality Assurance or related role within a GxP-regulated environment.
• Working knowledge of GxP requirements and quality systems.
• Practical experience with CAPA investigations and corrective actions.
• Experience conducting or supporting quality audits including follow-up activities.
• Experience in an electronic Quality Management System (eQMS) preferred.
• Other equivalent education/experience may be accepted.

Responsibilities

• Independently plan, conduct, document, and close internal audits to assess compliance.
• Review audit observations, communicate findings, and track corrective actions.
• Support CAPA activities from initiation through investigation and closure.
• Monitor audit and CAPA metrics, analyze trends, and report quality performance.
• Host customer audits and support regulatory inspections, including prep and follow-up.
• Provide QA guidance on compliance requirements across Protein Biomarkers departments.
• Maintain documentation in the eQMS and support training/continuous improvement.

Skills

Communication

Analytical

Independent

Audit planning

CAPA investigations

Education

Bachelor's degree

Equivalent combination

Tools

eQMS

Job description

IQVIA Laboratories in Austin, TX is seeking a Quality Assurance Auditor 2 to join the Protein Biomarkers Quality Assurance team. This role focuses on internal audits, CAPA oversight, regulatory readiness, and quality system performance to support client audits and inspections.

The position requires a Bachelor’s degree with 3 years in a GxP-regulated QA environment, strong CAPA and audit experience, and working knowledge of GxP.