Description
We are seeking a Quality Assurance Auditor 2 to join IQVIA Laboratories in Austin, TX. The successful candidate will play a key role within the Protein Biomarkers Quality Assurance team, supporting the effectiveness and compliance of quality systems through internal auditing, CAPA oversight, and continuous improvement initiatives.
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
Requirements:
- 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
- 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
- Experience working within an electronic Quality Management System (eQMS) is preferred
The Knowledge, Skills and Abilities Needed for This Role:
- Strong written and verbal communication skills with the ability to communicate effectively across multiple functions and organizational levels
- Strong analytical and problem-solving skills with the ability to exercise sound judgment and make informed decisions
- Ability to work independently, manage competing priorities, build collaborative relationships, and drive activities through completion
- Experience independently planning, conducting, reporting, and following up internal audits is preferred
- Experience reviewing investigations, root cause analyses, CAPA plans, and effectiveness checks is preferred
- Experience supporting or hosting customer audits and regulatory inspections is preferred
What We Offer You:
- Competitive salary: $54,200.00 - $135,400.00 per year
- Comprehensive benefits program, including physical, mental and emotional, financial and social well-being support