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Job Description

The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing study protocol, report/data and in-lab phase audits where applicable for multiple business areas. The auditor leads internal and external facility/process and/or supplemental inspections, provides recommendations for improving compliance, and prepares and delivers training in performance of audits. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role.

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Key Skills

GLP (Good Laboratory Practice)

Inspection Reports

Compliance Issues

Liaison with internal and external auditors

regulatory procedures