Quality Assurance Technical Reviewer
Mentor Technical Group • Vega Baja, Puerto Rico
Role Description
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 ensures 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: Review and audit validation, qualification, and verification activities across manufacturing, packaging, utilities, facilities, laboratories, and systems.
Participate in defining validation/qualification strategies for product transfers and site product changes, including regulatory impact assessments.
Review and approve Operational Qualification (OQ), Performance/Process Qualification (PQ), and Verifi...