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About the Role
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.
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)
- Other equivalent combination of education, training, and experience may be accepted in lieu of degree
Skills
- Strong written and verbal communication skills
- Strong analytical and problem-solving skills
- 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
- Experience reviewing investigations, root cause analyses, CAPA plans, and effectiveness checks
- Experience supporting or hosting customer audits and regulatory inspections
Location
- Austin, TX
Work Type
- Full-time
Experience Level
- 3 years of experience
Education Level
- Bachelor's degree
Salary/Compensations
- $54,200.00 - $135,400.00
Benefits
- Integrated benefits programs and resources to take care of employees' physical, mental and emotional, financial and social well-being
About the Company
- IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Equal Opportunity
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.