Senior Quality Lead-ISO 17025 Auditor-W2 ONLY

Lead and support the remediation of previous audit observations, including root cause analysis, risk based corrective action planning, and effectiveness verification.

Coordinate and conduct 6 onsite internal audits of laboratory operations and management systems to assess compliance with ISO 17025.
Identify nonconformities, document audit findings, and develop actionable recommendations.
Maintain audit schedules, records, and reporting documentation.
Support accreditation readiness and provide guidance on client inquiries.
Quickly elevate and provide recommendation for timely remediation on newly identified high risks gaps to client stakeholders.
Collaborate cross-functionally with laboratory, quality, and technical teams to sustain a robust audit and compliance culture.
Requirements:

Bachelor's degree and relevant GxP work experience.

Strong demonstrated expertise knowledge of ISO/IEC 17025:2017
11+ experience performing quality remediation and auditing execution activities.
Demonstrated ability to manage remediation of audit findings and supporting CAPA development and effectiveness.
Experience leading and managing site-wide Quality Assurance/Remediation Projects.
Proficiency with regulations related to FDA / MHRA regulations
Use of computerized quality management systems
Use of Quality metrics, dashboards, analysis and improvement programs.
Proficiency in using Microsoft Office Applicaitons.