Documentation Specialist (Regulated Industry)

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: 

1. Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
2. Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
3. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

1. Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly related experience. 
2. Experience in Change Control, CAPA, VAPA EV, Deviations, and Documentation handling.
3. Fully Bilingual (Spanish & English)
4. Available for rotative shifts 

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.