Senior Quality Assurance Auditor - Bioanalytical Lab

Elevate your career as a Senior Quality Assurance Auditor in the Bioanalytical Lab. Based onsite in North York, your role ensures compliance with regulatory standards and auditing protocols.

This full-time position centers on planning and conducting quality assurance audits in both clinical and non-clinical environments. As a Senior QA Auditor, you will leverage your expertise in Good Laboratory Practices (GLP) and Good Clinical Practice (GCP) to assess adherence to study protocols and company SOPs. You will report findings to management and contribute to maintaining high compliance standards within the laboratory.

Key Responsibilities:

• Conduct audits of Bioanalytical studies for GLP compliance

• Review Method Validation activities and raw data

• Perform facility and process audits, including equipment and training records

• Audit clinical trials for GCP and regulatory compliance

• Train QA staff on relevant SOPs and processes

Requirements:

• University degree in a scientific area

• 1-2 years QA experience with Phase 1 studies

• Strong knowledge of GLP, GCP, and regulatory guidelines

• Experience in SOP writing and review

• Excellent communication and organizational skills

Lead quality assurance efforts while ensuring compliance within the Bioanalytical Lab in North York.
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