Quality Assurance Auditor II

ICON plc • Portland, OR

27d • Hybrid

About The Position

Quality Assurance Auditor II - hybrid ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. Due the business function alignment of this role, there is a requirement for the individual to be onsite at the Laboratory 3 out of 5 days. 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.

Requirements

• Experience as a Quality Assurance/ Compliance Auditor
• Experience with, with ICH-GCP and with relevant GxP regulations and guidelines.
• BSc Degree is required
• Strong communication and relationship management skills
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• Experience within a Laboratory or Clinical environment in an advantage

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.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level