Quality Assurance Auditor

IQVIA•Ithaca, NY

1d•Onsite

About The Position

We are seeking a QA Auditor 1 to join IQVIA Laboratories at Ithaca, NY. 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: Support quality assurance audit activities by assisting lead auditors with planning, execution, documentation, and closure of audits and inspections in accordance with GxP regulations and internal quality systems.

Requirements

Bachelor’s degree preferred
Knowledge of GxP regulations and quality assurance auditing techniques
Proficiency with word processing, spreadsheet, and database applications
Strong interpersonal, organizational, and communication skills
Ability to manage multiple tasks and projects while meeting deadlines
Excellent problem‑solving skills with the ability to work independently
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Other equivalent combination of education, training, and experience may be accepted in lieu of degree

Responsibilities

Assist lead auditors in scheduling, conducting, reporting, and closing quality assurance audits within established timelines
Perform data reviews and file audits as directed and document audit activities in QA databases
Enter, categorize, and track audit and inspection findings in the electronic quality management system (eQMS)
Solicit follow‑up information from auditees and support closure of audit and inspection findings
Review and approve Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans
Support management of investigator derogatory status by maintaining compliance documentation and QA repositories
Assist in hosting customer audits, mock inspections, and regulatory inspections by acting as a scribe and coordinating documentation and interviews