We are seeking a
Quality Assurance Auditor 1 to join IQVIA Laboratories in a remote 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 Quality Assurance Auditor 1, you will assist lead auditors and audit liaisons in conducting, hosting, and reporting quality assurance audits. You will perform specific audit tasks under the direct supervision of more senior QA staff.
What you'll be doing:- Assisting in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor.
- Contacting auditees to agree on audit dates and make appropriate entries in the QA database.
- Performing data reviews and filing audits as directed.
- Entering and categorizing audit/inspection findings in eQMS.
- Soliciting follow-up information and closing audits/inspection findings in the QA database.
- Reviewing and approving Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans.
- Supporting investigators with derogatory status management in the database, preparing and releasing guidance documents with compliance information, and maintaining the QA repository with compliance information for investigators with derogatory status.
- Assisting in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe, reviewing documents, identifying and calling operational staff to answer related questions, and performing required administrative duties.
What we are looking for:- Bachelor's Degree in a relevant field.
- 1 year of Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience.
- Other equivalent combination of education, training, and experience may be accepted in lieu of degree.
The knowledge, skills, and abilities needed for this role:- Knowledge of word-processing, spreadsheet, and database applications.
- Considerable knowledge of GXP regulations and quality assurance auditing techniques.
- Strong interpersonal and problem-solving skills.
- Effective organization, communication, and team orientation skills.
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, 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 We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. 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. 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.