Quality Assurance Auditor 2

We are seeking a Quality Assurance Auditor 2 to join Q² Solutions, IQVIA’s laboratory business in Indianapolis, IN.

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 Auditor 2, you will be responsible for conducting and supporting audits, managing quality issues, and promoting compliance with regulations and corporate policies.

What You’ll be Doing:

• Planning, scheduling, conducting, reporting, and closing audit activities to assess compliance with regulations, customer requirements, SOPs, and project-specific guidelines.
• Evaluating audit findings and preparing and distributing reports to operations staff, management, and customers.
• Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Hosting audits/inspections and ensuring proper conduct of customer-initiated audits and mock regulatory inspections.
• Managing quality issues and overseeing quality events updates in eQMS.
• Reviewing, approving investigations, RCA, CAPA, and EC plans. Tracking until closures for quality events.
• Presenting educational programs and providing guidance to operational staff on compliance procedures.
• Providing quality assurance consultancy activities and projects for clients within budget and established timelines.

What We Are Looking For:

• Bachelor’s Degree preferred.
• 3 years’ experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.
• 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 interpersonal skills and excellent problem-solving skills.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects and 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, 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 Q² Solutions, IQVIA’s laboratory business, to help make the extraordinary possible!

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $70,900.00 - $106,300.00. 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.