We are seeking a Quality Assurance Audit Associate to join IQVIA Laboratories at Durham, NC.
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 Summary:
Assist lead auditors and audit liaisons in conducting, hosting, and reporting quality assurance audits by performing defined audit tasks under the supervision of senior QA staff. Support the audit lifecycle to ensure compliance with GXP standards and internal quality systems.
What You'll Be Doing:
- Support the planning and execution of quality assurance audits by scheduling, coordinating, and documenting audit activities as directed
- Perform data reviews and file audits and input audit data into QA systems accurately
- Enter and categorize audit and inspection findings within the electronic quality management system (eQMS)
- Solicit follow-up information from stakeholders and assist in the closure of audit findings
- Review and support approval of Corrective and Preventative Action (CAPA) and Effectiveness Check plans
- Assist in hosting customer audits and regulatory inspections, including acting as a scribe and coordinating document review
- Maintain QA documentation repositories and support investigator compliance tracking within QA databases
What We Are Looking For:
- Bachelor's Degree preferred
- 1 year Quality Assurance experience in pharmaceutical, technical, or related area, would be a plus
- Knowledge of GXP regulations and quality assurance auditing techniques
- Experience with electronic quality management systems (eQMS) and Microsoft Office applications
- Previous experience working within a regulated laboratory environment
- Familiarized with good documentation practices (GDP)
- 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 organizational, problem-solving, and multitasking abilities
- Effective communication and interpersonal skills with the ability to work collaboratively across teams
- Ability to manage multiple priorities, work independently, and maintain attention to detail
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 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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $43,400.00 - $108,500.00. 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.
