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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

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 (e.g. FDA CFRs, REACH, RoHS, Conflict Minerals, EHS, DFAR) as well as customer requirements or notifications (e.g. Q-Notes, SCN, MTG Quality Statement Quality is important to our business because we value our customers. We strive to provide our customers with products and services which meet and even exceed their expectations. We are committed to continuous improvement and have established a Quality Management System which provides a framework for measuring and improving our performance. Compliance Specialist 2018 2 Job Description GIDEP).
• 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.

Qualifications Requirements/Knowledge/Education/Skills:

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

Physical Requirements and Working Environment:

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment's, tools, or controls.  The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell.  The employee may lift and/or move up to 25-35 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.
• He / she may frequently work inside weather conditions, near moving mechanical parts, exposed to wet and or humid conditions, and an odorous atmosphere, may be exposed to fumes and the risk of electrical shock, and occasionally work on ladders in high places, in small spaces, such as lift/metering stations, manholes, tanks and wet wells.  The noise level in the work environment is usually moderately loud. 

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.