Quality Assurance Auditor II
About The Position
ICON is seeking a Quality Assurance Auditor to join its global Laboratory Auditing Team in Cambridge, Massachusetts. The role partners with internal stakeholders and performs a range of audit activities in a laboratory environment. The position is hybrid, with onsite work at the laboratory required three out of five days due to the role’s business function alignment. The auditor works within standardized procedures and practices to meet objectives, quality standards, and deadlines. The role also provides quality-related advice to operations, escalates quality and compliance concerns, reviews and helps maintain procedures, and may support case-management processes involving serious breaches, risk cases, and suspected scientific misconduct.
Requirements
- Experience as a Quality Assurance or Compliance Auditor.
- A BSc degree is required.
- Experience with ICH-GCP and relevant GxP regulations and guidelines.
- Strong communication and relationship-management skills.
Nice To Haves
- Experience within a laboratory or clinical environment is an advantage.
Responsibilities
- Conduct internal and vendor audits, external audits and inspections, and study audits in the laboratory environment.
- Review SOPs and other documentation, and manage CAPAs.
- Work within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.
- Provide quality-related advice to operations.
- Escalate quality and compliance issues to Quality & Compliance Line Management and relevant ICON functions as appropriate.
- Perform Quality & Compliance reviews of SOPs when assigned and contribute to the development and 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
