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Regulatory Compliance Analyst
2 months ago
Mentor Technical Group (MTG) is a leading provider of technical support and solutions tailored for the FDA-regulated sector. With extensive expertise in life science engineering, MTG is committed to ensuring adherence to safety and efficacy standards in pharmaceuticals, biotechnology, and medical devices.
Key Responsibilities:
- Assist the Facilities Team in ensuring that Compliance standards are upheld before, during, and after field operations related to facility activities conducted by contractors.
- Oversee all aspects of the Contractor Safety Program.
- Provide inspection and monitoring services for facility operations to ensure adherence to established procedures, policies, and guidelines.
- Evaluate facility Standard Operating Procedures (SOPs) to ensure alignment between documented procedures and actual practices.
- Prepare for audit readiness.
- Conduct random reviews of facility documentation using statistical methods and report findings.
- Develop a Compliance enhancement plan based on review outcomes when necessary.
- Execute internal audits and routine inspections of areas managed by Mentor and its subcontractors.
- Ensure follow-up on training for all Mentor personnel and subcontractors.
- Support the investigation of incidents related to Pest Control, Facilities, and Environmental Health and Safety (EHS).
- Track and present Compliance Key Performance Indicators (KPIs) during Site Management Team meetings.
- Promote Compliance Awareness among Mentor staff.
- Engage in discussions focused on Compliance Awareness.
- Bachelor's degree in a scientific field preferred, with 5-10 years of experience in EHS and Good Manufacturing Practices (GMP) within a manufacturing and utilities environment.
