Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to join IQVIA Laboratories in 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.

As a Quality Assurance Specialist, you will support the data processing function for the maintenance of the QA database(s) supporting the Quality Assurance Unit.

What You’ll Be Doing

• Maintaining the QA database(s), ensuring audits are entered from audit plans/notification documentation and the system is updated as required.
• Following up on audit information, including missing information, confirmation of audits performed, report issuance, and corrective and preventive actions.
• Tracking documentation related to the QA auditing lifecycle, including internal, external, contracted, and customer audits, regulatory inspections, quality issues, and status of critical/major issues.
• Producing documentation from the QA database(s), including status reports of overdue information, tables, and graphs as required.
• Maintaining the QA filing systems for QMS lifecycle tracking, including electronic filing of documentation, archiving records, proficiency documentation, and correspondence.
• Providing timely feedback to line management on QMS lifecycle system status.
• Supporting the proficiency program by scheduling, coordinating, testing, and authoring reports.
• Providing support to staff by answering simple queries concerning the use of QEM.
  
  

What We Are Looking For

• Associate’s Degree in a chemical, physical, or biological science or medical laboratory technology from an accredited institution (CLIA requirement for Testing Personnel).
• 1 year of relevant experience in a quality/laboratory environment, including GXP and/or Quality Assurance experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Knowledge of GXP regulations and guidelines.
• Other equivalent combination of education, training, and experience may be accepted in lieu of degree.
  
  

The Knowledge, Skills, And Abilities Needed For This Role

• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  
  

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, 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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $44,000.00 - $73,300.00. 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.