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Quality Assurance Auditor 2

IQVIA
  • Austin, Texas
    12 days ago

    Job Description

    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.

    Numbers & Facts

    LocationAustin, Texas
    IndustryHealthcare Services
    Company Size10,000 employees or more
    Year Founded1982
    Websitehttps://www.iqvia.com/

    About Company

    IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.

    Skills

    • Analysis Skillsunmatched
    • Audit Metricsunmatched
    • Auditingunmatched
    • Biologyunmatched
    • Biomarkersunmatched
    • Biotech and Pharmaceuticalunmatched
    • Clinical Laboratoryunmatched
    • Clinical Researchunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Customer Support/Serviceunmatched
    • Documentationunmatched
    • GxPunmatched
    • Healthcareunmatched
    • Internal Auditunmatched
    • Laboratoryunmatched
    • Maintain Complianceunmatched
    • Medical Treatmentunmatched
    • Patient Careunmatched
    • Performance Analysisunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Quality Assuranceunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Research & Development (R&D)unmatched
    • Research Laboratoryunmatched
    • Root Cause Analysisunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Playerunmatched
    • Trend Analysisunmatched
    • Writing Skillsunmatched

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