QA Auditor II

ICON · Cambridge, MA · $68,616.00-$85,770.00 · hybrid ICON is seeking a Quality Assurance Auditor to join our Laboratory Auditing Team. You will partner with internal stakeholders, performing a variety of audit activities within our Laboratory environment. Responsibilities include: 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 needed Performing Quality & Compliance review of SOPs and contributing to the development & maintenance of departmental and general procedures Supporting case management processes, including potential serious breaches, risk cases, and suspected scientific misconduct cases Requirements: Experience as a Quality Assurance/Compliance Auditor Experience within a Laboratory or Clinical environment is an advantage Experience with ICH-GCP and relevant GxP regulations and guidelines BSc Degree required Strong communication and relationship management skills ICON offers a competitive and comprehensive total rewards package, including: Competitive base salary and performance-related incentives Health and wellbeing programmes, including medical, dental, and vision coverage 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