We are seeking a Quality Assurance Auditor 1 to IQVIA’s Laboratory's at Durham, North Carolina.

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 Overview: Assist lead auditors/audit liaisons in conducting, hosting, and reporting quality assurance audits by performing specific audit tasks under the direct supervision of more senior QA staff.

What you’ll be doing:

• Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in QA database, performing data reviews, and file audits as directed.
• Enter and categorize audit/inspection findings in eQMS.
• Solicit follow-up information and close audits/inspection findings in the QA database.
• Review and approve Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans.
• Support Investigators derogatory status management in the database, prepare and release guidance documents with compliance information, and maintain the QA repository with compliance information for investigators with derogatory status.
• Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe. Review documents, identify and call operational staff to answer related questions. Perform required administrative duties including tracking of documents reviewed, scheduling audit team members for interviews, and copying and stamping documents for release to the auditors/inspectors.
• Obtain a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques.
• Provide QA consultancy where possible.
• Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.

What We Are Looking For:

• Bachelor's Degree preferred.
• 1 year Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience. Equivalent combination of education, training, and experience may be accepted in lieu of degree.
• Knowledge of word-processing, spreadsheet, and database applications.
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.

The Knowledge, Skills, and Abilities needed for this role:

• Strong interpersonal skills.
• 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.
• 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 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’s laboratory's business, 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 $51,500.00 - $85,800.00. 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.