Quality Assurance Auditor II - GxP & CAPA Expert

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

Job summary

IQVIA Laboratories in Austin, TX, seeks a Quality Assurance Auditor 2 to support internal audits, CAPA oversight, and continuous improvement across Protein Biomarkers. The role ensures compliance with GxP and prepares for customer audits and regulatory inspections.

The position requires a Bachelor's degree and 3 years of QA experience in a regulated environment, with strong CAPA and audit skills. On-site work in Austin, TX, is expected.

Qualifications

• Bachelor's degree or equivalent combination of education, training, and relevant experience.
• 3 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 (required).
• Practical experience with CAPA, investigations, or quality events, including root cause analysis and corrective actions (required).
• Experience conducting or supporting quality audits, including audit preparation, execution, reporting, and follow-up activities (required).
• Experience working within an electronic Quality Management System (eQMS) (preferred).
• Other equivalent combination of education, training, and experience may be accepted in lieu of degree.

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.

Skills

Quality Assurance

GxP

CAPA investigations

Internal audits

eQMS

Regulatory inspections

Root cause analysis

Audit reporting

Cross-functional collaboration

Education

Bachelor's degree

Tools

eQMS

Job description

IQVIA Laboratories in Austin, TX, seeks a Quality Assurance Auditor 2 to support internal audits, CAPA oversight, and continuous improvement across Protein Biomarkers. The role ensures compliance with GxP and prepares for customer audits and regulatory inspections.

The position requires a Bachelor's degree and 3 years of QA experience in a regulated environment, with strong CAPA and audit skills. On-site work in Austin, TX, is expected.