Compliance Specialist

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada and South America. 

ESSENTIAL FUNCTIONS: (A summary of the purpose of the position)

Our Compliance Specialist will perform administrative tasks to ensure all compliance functions are completed; and, will be responsible for reviewing customer PO requirements as well as compliance and other regulatory requests.  Also, will be responsible for the development and implementation of a strategy to ensure the client requirements are met.

EDUCATIONAL or EQUIVALENT REQUIREMENTS: (Minimum required to perform the job)

1. Bachelor's degree in Business Administration or relevant work experience
2. 3-10 years of compliance experience within a manufacturing environment
3. Ability to understand commercial, quality and technical requirements
4. Excellent organizational and oral communication skills
5. Computer literacy with MS Office applications

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES:

• Lead the review and administration of customer contract reviews as it pertains to quality and compliance requirements.
• Complete customer surveys and complete checked tasks.
• Develop and maintain a system for tracking services compliance.
• Accountable for compliance with international, federal, state, and local regulatory requirements.
• Act as a point of contact for customers, suppliers, and internal employees with regard to all contracts and compliance requests.
• Generate product certificate of compliance or test documents for required customer orders.
• Work with all necessary internal departments to ensure compliance requirements are achieved as related to industry and customer expectations based on customer driven goals
• Management of all regulatory aspects including external and internal audits, investigations and corrective/preventive actions.
• Ensure the adherence of our employees to the standard operating procedures (SOPs) established by the clients.
• Manage an internal audit process to assure the adherence of the client SOPs
  Any other duties as required by Site Lead (or direct supervisor) to support normal client site operations. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.