Documentation Specialist

MENTOR Technical Group Corporation; Caguas (PR); On-site; USD 35,000 - 52,000; Full time

Job summary

Mentor Technical Group (MTG) is seeking a Documentation and Compliance Specialist in Puerto Rico. The role supports cGMP and ISO 17025 related activities, providing technical guidance to ensure operations meet government policies in a cost‑effective and timely manner.

The candidate will prepare and revise SOPs, DIs, and forms, maintain client relations, and participate in identifying opportunities for MTG. A BA in business administration and strong software skills are required, with emphasis on

Qualifications

• BA in Business Administration
• Proficient in computer software programs such as word processors, spreadsheet programs, and database systems
• Basic analytical experience
• Proficient typing skills
• Data organization and storage knowledge

Responsibilities

• Perform all functions with direct supervision.
• Documentation activities according to project assignment and customer requirements, in compliance with cGMPs and Safety procedures.
• Provide technical support to ensure operations comply with policies and regulations in a cost‑effective manner and on time.
• Prepare necessary documentation under supervision.
• Revise SOPs, Work Instructions, and Forms to comply with ISO 17025:2017.
• Maintain customer‑oriented behavior and clear communication with clients.
• Ensure quality of the product delivered to clients.
• Promote strong relationships with MTG clients and professional conduct.
• Review work quality, obtain client feedback, and monitor status vs. client requirements.
• Identify project opportunities by providing technical expertise.
• Comply with MTG administrative requirements (Time Sheets, CV updates, etc).
• Keep up with regulatory trends affecting validation and compliance in pharma, biotech, food and healthcare.
• Other duties as assigned by supervisor/management or client.

Skills

Proficient typing skills

Basic analytical experience

Data organization & storage knowledge

Education

BA in Business Administration

Tools

Word processors

Spreadsheets

Database systems

Job description

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. Performs all functions listed below with direct supervision.
• 2. Perform activities related with Documentation according to project assignment, customers’ needs and requirements and incompliance with cGMP’s and Safety procedures
• 3. Provide technical support and advice to assure that operational activities are performed in compliance with corporate/government policies and regulations in a cost-effective way and within the timelines established by the customer.
• 4. Performed all the documentations required by the direct supervisor.
• 5. Revision of Standard Operating Procedure, Work Instruction and Forms required to comply with ISO 17025 : 2017
• 6. Exhibit a customer oriented behavior, by clearly understanding customers’ needs and expectations, and anticipatingpossible barriers or obstacles that may impact the project(s) adversely, and communicating these on a timely manner.
• 7. Incumbent is responsible for the quality of the product provided to client customers.
• 8. Promote excellent relationship with MTG clients, encouraging an open dialog and trustful communication between bothparties demonstrating a professional conduct at all times and proudly represent MTG at all levels and places
• 9. Guarantee top quality of services provided to client by reviewing work performed, documentation submitted, get hold ofclient feedback and monitoring project status vs. client requirements.
• 10. Maintain a proactive attitude towards the development of new business opportunities.
• 11. Alerts management when problems are identified and makes recommendations for improvements.
• 12. When required, actively participates in identifying project opportunities by providing the necessary technical expertise.This responsibility emphasizes opportunities for customer as well as for MTG.
• 13. Comply with MTG administrative requirements such as: Time Sheets, updating of CV’s, yearly updates of medical andGood Conduct Certificate, attendance to work, etc.
• 14. Keep up with current trends and changes of regulations applicable to validation and compliance within all areas of thePharmaceutical, Biotechnology, Food and Beverage, Cosmetics and Healthcare Industry business
• 15. Other responsibilities as assigned by supervisor/management, and/or client

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities and activities may change at any time with or without notice.

Education & Qualifications

• 1. BA in Business Administration
• 2. Proficient in computer software programs such as, word processors, spreadsheet programs, and database systems
• 3. Basic analytical experience
• 4. Proficient typing skills
• 5. Data organization and storage knowledg

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.

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.