The Quality Assurance Specialist is responsible for auditing manufacturing processes and reviewing batch records, ensuring compliance in FDA-regulated industries.
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:
- Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
- Available for non-standard shifts which include nights and weekends.
- Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS.
- Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly related experience. (Science and Engineering preferred)
- Fully Bilingual (Spanish & English)
- Available for rotating shifts
Top Skills
Lims
Maximo
Mes
Pasx
SAP
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