QA Auditor 2

We are seeking a QA Auditor 2 to join IQVIA Laboratories in Durham, NC in a hybrid position.

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 QA Auditor 2, you will be conducting and supporting audits, managing quality issues, hosting customer audits and regulatory inspections, and reviewing CAPA and EC plans. You will also be providing consultation on regulations and compliance, and supporting QA initiatives for process improvements.

What you’ll be doing:

• Planning, scheduling, conducting, reporting, and closing audit activities to assess compliance with regulations, guidelines, customer requirements, SOPs, and project-specific instructions.
• Evaluating audit findings and preparing/distributing reports to operations staff, management, and customers.
• Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies/procedures.
• Hosting audits/inspections and assisting in regulatory facility inspections.
• Managing quality issues and tracking closures for quality events arising from audits, inspections, or QA activities.
• 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.
• Maintaining the electronic quality management system (eQMS) and supporting the audit lifecycle.
  
  

What we are looking for:

• Bachelor's Degree preferred.
• 3 years of experience in pharmaceutical, technical, or related areas including GXP and/or Quality Assurance experience. Other 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 and excellent problem-solving skills.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and work independently.
• Ability to manage multiple projects and establish 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

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

The potential base pay range for this role, when annualized, is $67,500.00 - $112,500.00. 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.