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Regulatory Compliance Analyst
2 months ago
Mentor Technical Group (MTG) stands as a prominent provider of technical support and solutions tailored for the FDA-regulated sector. As a leader in life science engineering and technical services, MTG possesses the expertise to ensure 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 the execution of field operations related to facilities managed by contractors.
- Oversee all aspects of the Contractor Safety Program to ensure compliance.
- Conduct inspections and monitoring of facility activities to verify 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 and maintain documentation accordingly.
- Randomly review facility documentation using statistical methods and compile reports on findings.
- Develop and implement a Compliance enhancement plan based on audit results, if necessary.
- Carry out internal audits and routine inspections of areas overseen by Mentor and its subcontractors.
- Ensure that all Mentor associates and subcontractors receive appropriate training and follow-up.
- Support investigations related to Pest Control, Facilities, and Environmental Health and Safety (EHS) incidents.
- Track and present Compliance Key Performance Indicators (KPIs) during Site Management Team meetings.
- Promote Compliance Awareness among Mentor associates.
- Engage in discussions focused on Compliance Awareness.
- Bachelor's degree in a scientific discipline preferred; 5-10 years of experience in EHS and Good Manufacturing Practices (GMP) within a manufacturing environment and utilities.
