Quality Assurance Auditor II

About the role

Quality Assurance Auditor II - hybrid

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The role:

We are looking for a Quality Assurance Auditor to join our Global vibrant and passionate Laboratory Auditing Team. You will partner with internal stakeholders, performing a variety of audit activities with our Laboratory environment.

Responsibilities

• Performing tasks relevant to our Lab environment such as conducting internal and vendor audits, external audits/inspections, study audits, SOP and documentation review and CAPA management.
• Working within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.
• Providing advice to operations on quality related issues
• Escalating quality and compliance issues to Quality & Compliance Line Management and relevant ICON functions as appropriate
• Performing Quality & Compliance review of SOPs when designated this responsibility, and contribute to the development & maintenance of departmental and general procedures
• If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.

Experience and qualifications required

• Experience as a Quality Assurance/ Compliance Auditor
• Experience within a Laboratory or Clinical environment in an advantage
• Experience with, with ICH-GCP and with relevant GxP regulations and guidelines.
• BSc Degree is required
• Strong communication and relationship management skills