Quality Assurance Auditor 2

IQVIA • Austin, TX

3d

About The Position

IQVIA Laboratories is seeking a Quality Assurance Auditor 2 to join the Protein Biomarkers Quality Assurance team in Austin, Texas. The role supports the effectiveness and compliance of quality systems through internal auditing, CAPA oversight, and continuous improvement initiatives. It works across departments to provide Quality Assurance guidance, ensure compliance with applicable GxP requirements, and support customer audits, regulatory inspections, and quality system performance.

Requirements

• Bachelor's degree or equivalent combination of education, training, and relevant experience; an equivalent combination may be accepted in lieu of a degree.
• Three years of experience in Quality Assurance or a related role within a GxP-regulated pharmaceutical, laboratory, clinical research, or similar environment.
• Working knowledge of GxP requirements and quality systems, with the ability to interpret and apply requirements in a regulated environment.
• Practical experience with CAPA, investigations, or quality events, including root cause analysis and corrective actions.
• Experience conducting or supporting quality audits, including audit preparation, execution, reporting, and follow-up activities.
• Strong written and verbal communication skills, including the ability to communicate effectively across multiple functions and organizational levels.
• Strong analytical and problem-solving skills, sound judgment, and the ability to make informed decisions.
• Ability to work independently, manage competing priorities, build collaborative relationships, and drive activities through completion.

Nice To Haves

• Experience working within an electronic Quality Management System (eQMS).
• Experience independently planning, conducting, reporting, and following up internal audits.
• Experience reviewing investigations, root cause analyses, CAPA plans, and effectiveness checks.
• Experience supporting or hosting customer audits and regulatory inspections.

Responsibilities

• Independently plan, conduct, document, and close internal audits to assess compliance with applicable regulations, client requirements, SOPs, and quality standards.
• Review audit observations, communicate findings, and track corrective actions through completion.
• Support CAPA activities from initiation through investigation, action planning, effectiveness checks, and closure.
• Monitor audit and CAPA metrics, analyze trends, and contribute to quality performance reporting.
• Host customer audits and support regulatory inspections, including preparation, responses, and follow-up activities.
• Provide Quality Assurance guidance on compliance requirements, quality systems, policies, and procedures across Protein Biomarkers departments.
• Maintain accurate documentation within the electronic Quality Management System and support training and continuous improvement initiatives.

Benefits

• Integrated benefits programs and resources supporting employees' physical, mental, emotional, financial, and social well-being.
• Health and welfare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level