We are seeking Quality Assurance Auditor 2 to join IQVIA Laboratories at Austin, TX.Job Summary:The Quality Assurance Auditor 2 plays 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. This position works across departments to provide Quality Assurance guidance, ensure compliance with applicable GxP requirements, and support customer audits, regulatory inspections, and quality system performance.
What You'll Be Doing:- 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
What We Are Looking For:- 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
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 (preferred)
- Experience reviewing investigations, root cause analyses, CAPA plans, and effectiveness checks (preferred)
- Experience supporting or hosting customer audits and regulatory inspections (preferred)
What We Offer You:We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.
To learn more about our benefits, visit https://jobs.iqvia.com/benefits.
If you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!
The potential base pay range for this role, when annualized, is $54,200.00 - $135,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
