Quality Assurance Auditor 2

IQVIA Laboratories; Austin (TX); Vor Ort; USD 54.000 - 135.000; Vollzeit

Zusammenfassung

IQVIA Laboratories in Austin, TX seeks a Quality Assurance Auditor 2 to ensure compliance of quality systems through internal audits, CAPA oversight, and continuous improvement initiatives.

You will support customer audits, regulatory inspections, and review findings to drive corrective actions within an electronic Quality Management System. Requires a bachelor’s degree and 3+ years in a GxP environment.

Qualifikationen

• Bachelor's degree or equivalent; education, training, and experience accepted in lieu of degree (GxP environment preferred).
• 3 years of experience in Quality Assurance or related role within a GxP-regulated environment.
• Working knowledge of GxP requirements and quality systems and ability to apply them in regulated settings.
• CAPA investigations, root cause analysis, and corrective actions experience (required).
• Experience conducting or supporting quality audits, including preparation, execution, reporting and follow-up (required).

Aufgaben

• Independently plan, conduct, document, and close internal audits to assess compliance with 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 QA 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.

Kenntnisse

GxP experience

CAPA investigations

Audits & inspections

eQMS

Ausbildung

Bachelor's degree or equivalent

Tools

eQMS

Jobbeschreibung

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 decisionsAbility 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.

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. 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. 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.