Documentation Specialist

Posted 2 Days Ago
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Juncos
Mid level
Consulting • Pharmaceutical
The Role
The Documentation Specialist at Mentor Technical Group will support quality systems and manufacturing operations by applying expertise in compliance and processes. Responsibilities include handling documentation, process validation, and aiding in training for new products. The role requires bilingual capabilities in Spanish and English, and a solid background in regulatory compliance is essential.
Summary Generated by Built In

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.

Education & Qualifications

  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 
The Company
South San Francisco, CA
265 Employees
On-site Workplace
Year Founded: 2000

What We Do

MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology.

MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology.

MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution.

At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.

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