Sr. Documentation Specialist

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, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• Perform assigned functions under direct supervision, ensuring accuracy and compliance with established procedures.
• Execute documentation-related activities according to project assignments, client requirements, and in compliance with cGMP and safety procedures.
• Provide technical support and guidance to ensure operational activities comply with corporate and regulatory policies in a cost-effective and timely manner.
• Prepare, review, and maintain all documentation required by the direct supervisor.
• Review and update Standard Operating Procedures (SOPs), Work Instructions (WIs), and forms to ensure compliance with regulatory standards.
• Ensure all work performed aligns with site objectives and meets client expectations and satisfaction.
• Support training and coaching of Mentor Technical Group personnel, when required, to ensure proper knowledge and effective performance of duties.
• Demonstrate strong customer-oriented behavior by understanding client needs, anticipating potential challenges, and communicating risks proactively.
• Ensure the quality of deliverables provided to clients by maintaining accuracy and compliance in all work products.
• Maintain professional relationships with MTG clients, fostering open communication, trust, and a high level of professionalism.
• Ensure high-quality service delivery by reviewing completed work, monitoring project status, incorporating client feedback, and verifying alignment with requirements.
• Maintain a proactive approach to identifying and supporting new business opportunities.
• Communicate issues to management promptly and provide recommendations for continuous improvement.
• Participate in identifying project opportunities by contributing technical expertise for both client and MTG benefit.
• Comply with MTG administrative requirements, including timesheets, CV updates, certifications, and attendance policies.
• Stay updated with current industry trends and regulatory changes applicable to validation and compliance within the pharmaceutical, biotechnology, food & beverage, cosmetics, and healthcare industries.
• Perform other duties as assigned by supervisor, management, or client.

Qualifications / Requirements / Knowledge / Education / Skills:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Experience in regulated industries such as pharmaceutical, biotechnology, medical devices, or similar environments is preferred.
• Knowledge of cGMP, FDA regulations, and quality systems.
• Strong understanding of documentation practices including SOP revisions, work instructions, and technical reports.
• Ability to provide technical support and ensure compliance with corporate and regulatory requirements.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Customer-focused mindset with the ability to build and maintain professional relationships.
• Ability to work effectively under supervision and within multidisciplinary teams.
• Proficiency in Microsoft Office and documentation management systems is a plus.
• Bilingual (English/Spanish) is preferred.