# QA Auditor II

**Company**: ICON
**Location**: Cambridge, MA
**Work arrangement**: hybrid
**Job type**: full-time
**Salary**: $68,616.00-$85,770.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Cambridge-MA/Quality-Assurance-Auditor-II_JR162106?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/qa-auditor-ii-129ce6e5-7d7/

## Description

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

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## Skills

### Required
- ICH-GCP
- GxP regulations
- Quality Assurance
- Compliance
- Laboratory environment

### Nice to have
- Laboratory experience
- Clinical environment experience

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Cambridge-MA/Quality-Assurance-Auditor-II_JR162106?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)