Sr Quality Assurance Auditor

At Clario, a part of Thermo Fisher Scientific, the Senior Quality Assurance Auditor plays a key role in maintaining regulatory compliance and strengthening our Quality Management System (QMS). You will lead and support internal, external, vendor, customer, and regulatory audits while partnering with cross-functional teams to identify compliance risks, resolve quality events, and drive continuous improvement. This is an opportunity to apply your quality expertise while providing guidance and mentorship across the organization.

What We Offe r

• Competitive compensation
• Medical, dental, and vision coverage
• Tuition reimbursement
• Employee assistance and wellness programs
• Life and disability insurance

What You’ll Be Doin g

• Plan, conduct, lead, and report internal, external, vendor/supplier, customer, registrar, and regulatory audits in accordance with applicable Standard Operating Procedures (SOPs) and electronic document management system processes.
• Manage and monitor audit findings, quality events, corrective and preventive actions (CAPAs), root cause activities, and effectiveness checks through timely closure, escalating significant quality concerns when appropriate.
• Track and trend audit activities, compliance reports, CAPAs, and quality metrics, communicating significant trends and risks to management.
• Perform Quality Assurance reviews of source documents, case report forms (CRFs), reports, and system development and validation deliverables for accuracy, consistency, and compliance.
• Partner with development and cross-functional teams to identify compliance risks, resolve quality issues, and implement process improvements, with particular focus on the audit program and Quality Management System.
• Provide quality-related guidance and training to colleagues, support root cause analysis, and mentor personnel as assigned.
• Develop or revise SOPs, support departmental and regulatory standards, and maintain current technical and industry knowledge through applicable training.

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