QA Auditor II - Lab/GCP, Hybrid Role

KCR Placement; Cambridge (MA); Hybrid; USD 70,000 - 120,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance

Retirement planning offerings

Employee Assistance Program LifeWorks

Life assurance

Flexible country-specific optional ben

Childcare vouchers

Bike purchase schemes

Discounted gym memberships

Job summary

ICON is a global healthcare intelligence and clinical research organisation uniting a mission to bring new medicines to patients faster. The role is QA Auditor II in Cambridge, MA, operating in a hybrid laboratory environment.

Onsite is required 3 days out of 5, with the support of a dynamic team focused on quality and compliance. You will partner with internal stakeholders to perform a variety of laboratory audits, vendor inspections, SOP reviews and CAPA management, while upholding ICH-GCP and

Qualifications

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

Responsibilities

• Perform internal and vendor audits, external audits/inspections, study audits, SOP and documentation review and CAPA management.
• Work within standardized procedures to meet quality standards and deadlines.
• Provide advice to operations on quality related issues.
• Escalate quality and compliance issues to Quality & Compliance Line Management and ICON functions as appropriate.
• Review SOPs for quality/compliance and contribute to procedures development and maintenance.
• Support case management processes including serious breaches or misconduct cases when required.

Skills

Quality Assurance

Auditing

Communication

Regulatory knowledge

GxP

Education

BSc Degree

Job description

ICON is a global healthcare intelligence and clinical research organisation uniting a mission to bring new medicines to patients faster. The role is QA Auditor II in Cambridge, MA, operating in a hybrid laboratory environment.

Onsite is required 3 days out of 5, with the support of a dynamic team focused on quality and compliance. You will partner with internal stakeholders to perform a variety of laboratory audits, vendor inspections, SOP reviews and CAPA management, while upholding ICH-GCP and