Quality Assurance Auditor 2

Austin, Texas, United States of America

Full time

R1575316

We are seeking Quality Assurance Auditor 2 to join IQVIA Laboratories at Austin, TX.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

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!

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. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. 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. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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