Technical Compliance Specialist
hace 1 día
Mentor Technical Group is a leading provider of technical support and solutions for the FDA-regulated industry. We are seeking a skilled Technical Compliance Specialist to join our team.
About UsAs a world leader in life science engineering and technical solutions, we have the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. Our global presence spans six markets: the United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Job SummaryWe are offering an estimated salary range of $60,000 - $80,000 per year. The successful candidate will support the execution of manufacturing/quality systems, apply process and scientific expertise, and serve as primary production process owner for process support systems.
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.
- Serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
- 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.
Mentor Technical Group is an equal opportunity employer. We offer a comprehensive portfolio of benefits, including:
- A competitive salary range of $60,000 - $80,000 per year.
- A dynamic and supportive work environment.
- Ongoing training and professional development opportunities.
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