QA Auditor 1 - Hybrid
QA Auditor 1 - Hybrid
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Job Description
We are seeking QA Auditor 1 to join IQVIA Laboratories in Austin TX in a hybrid role.
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 1 you will be assisting lead auditors and audit liaisons in conducting hosting and reporting quality assurance audits. You will be performing specific audit tasks under the direct supervision of more senior QA staff.
What youll be doing:
- Conducting quality assurance audits within budget and established timelines by scheduling conducting reporting and closing audits as directed by the lead auditor.
- Entering and categorizing audit/inspection findings in eQMS.
- Soliciting followup 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.
- Hosting customer audits mock regulatory inspections and regulatory facility inspections by acting as a scribe reviewing documents and coordinating with operational staff.
- Obtaining a fundamental knowledge of current relevant GXP regulations guidelines and related auditing techniques.
- Providing QA consultancy where possible.
- Maintaining the electronic quality management system (eQMS) and supporting the audit lifecycle.
What we are looking for:
- Bachelors Degree preferred.
- 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.
- Knowledge of wordprocessing 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 problemsolving 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 wellbeing so they can thrive at home and at work at any stage of their wellbeing journey.
To learn more about our benefits visit youre 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
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. potential base pay range for this role when annualized is $51500.00 $85800.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.
Employment Type
Full-Time
