QA Auditor II - CAPA & GxP Compliance Lead

IQVIA Laboratories; Austin (TX); Vor Ort; USD 54.000 - 135.000; Vollzeit

Zusammenfassung

IQVIA Laboratories in Austin, TX seeks a Quality Assurance Auditor 2 to ensure compliance of quality systems through internal audits, CAPA oversight, and continuous improvement initiatives.

You will support customer audits, regulatory inspections, and review findings to drive corrective actions within an electronic Quality Management System. Requires a bachelor’s degree and 3+ years in a GxP environment.

Qualifikationen

• Bachelor's degree or equivalent; education, training, and experience accepted in lieu of degree (GxP environment preferred).
• 3 years of experience in Quality Assurance or related role within a GxP-regulated environment.
• Working knowledge of GxP requirements and quality systems and ability to apply them in regulated settings.
• CAPA investigations, root cause analysis, and corrective actions experience (required).
• Experience conducting or supporting quality audits, including preparation, execution, reporting and follow-up (required).

Aufgaben

• Independently plan, conduct, document, and close internal audits to assess compliance with regulations, client requirements, SOPs, and quality standards.
• Review audit observations, communicate findings, and track corrective actions through completion.
• Support CAPA activities from initiation through investigation, action planning, effectiveness checks, and closure.
• Monitor audit and CAPA metrics, analyze trends, and contribute to quality performance reporting.
• Host customer audits and support regulatory inspections, including preparation, responses, and follow-up activities.
• Provide QA guidance on compliance requirements, quality systems, policies, and procedures across Protein Biomarkers departments.
• Maintain accurate documentation within the electronic Quality Management System and support training and continuous improvement initiatives.

Kenntnisse

GxP experience

CAPA investigations

Audits & inspections

eQMS

Ausbildung

Bachelor's degree or equivalent

Tools

eQMS

Jobbeschreibung

IQVIA Laboratories in Austin, TX seeks a Quality Assurance Auditor 2 to ensure compliance of quality systems through internal audits, CAPA oversight, and continuous improvement initiatives.

You will support customer audits, regulatory inspections, and review findings to drive corrective actions within an electronic Quality Management System. Requires a bachelor’s degree and 3+ years in a GxP environment.