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.
Responsibilities:
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.
Qualifications / Requirements / Knowledge / Education / Skills:
Bachelor’s degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field.
Minimum of 5–10 years’ experience in deviation management, quality assurance, or compliance in FDA-regulated environments.
Previous experience working in aseptic processes or sterile manufacturing environments is required.
Strong understanding of GMP, FDA regulations, and quality systems.
Proficiency in English; additional language skills are a plus.
Experience with deviation tracking systems, CAPA management, and electronic quality management systems (eQMS).
Excellent analytical, organizational, and problem-solving skills.
Strong communication skills and ability to collaborate effectively across teams.
Skills Required
- Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
- Minimum of 5-10 years' experience in deviation management, quality assurance, or compliance in FDA-regulated environments.
- Previous experience working in aseptic processes or sterile manufacturing environments.
- Strong understanding of GMP, FDA regulations, and quality systems.
- Experience with deviation tracking systems, CAPA management, and electronic quality management systems (eQMS).
- Proficiency in English.
- Excellent analytical, organizational, and problem-solving skills.
- Strong communication skills and ability to collaborate effectively across teams.
What We Do
MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology. MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology. MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution. At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.
