Deviations Owner Investigator

Mentor Technical Group provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry.

Requirements

• Serve as the primary owner for deviations, ensuring proper documentation, investigation, and resolution in compliance with FDA and internal quality standards.
• Coordinate with production, QA/QC, and project teams to evaluate deviations, determine root cause, and implement corrective and preventive actions (CAPA).
• Maintain accurate records of deviations, investigations, approvals, and follow-up activities.
• Monitor deviation trends and provide reports to management to support continuous improvement initiatives.
• Ensure timely communication of deviation status and regulatory impact to relevant stakeholders.
• Support audits and inspections by providing evidence of deviation management and compliance.
• Collaborate in the development and optimization of deviation management processes and SOPs.

Benefits

• Equal opportunity employer