Quality Assurance Auditor
IQVIA•Durham, NC
•$43,400 - $108,500•Onsite
About The Position
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.
Requirements
- 1 year Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience.
- Knowledge of GXP regulations and quality assurance auditing techniques
- Experience with electronic quality management systems (eQMS) and Microsoft Office applications
- 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
Nice To Haves
- Bachelor's Degree preferred
- Equivalent combination of education, training and experience may be accepted in lieu of degree
Responsibilities
- 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
Benefits
- Integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
