Documentation Specialist (Regulated Industry)
About The Position
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 and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
Requirements
- Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly related experience.
- Experience in Change Control, CAPA, VAPA EV, Deviations, and Documentation handling.
- Fully Bilingual (Spanish & English)
- Available for rotative shifts
Responsibilities
- Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
- Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
