Documentation Specialist

Mentor Technical Group; Barceloneta (PR); On-site; USD 42,000 - 64,000; Full time

Job summary

Mentor Technical Group (MTG) seeks a documentation and compliance-focused professional in the life sciences sector. The role supports validation activities and ensures adherence to cGMP and ISO 17025:2017, with offices in Puerto Rico and Boston.

You will handle project documentation, SOP reviews, and client-facing support to maintain high-quality services for pharmaceutical, biotechnology, and medical device clients.

Qualifications

• BA in Business Administration.
• Proficient in computer software programs such as word processors, spreadsheets, and databases.
• Basic analytical experience and data management skills.
• Proficient typing skills and attention to detail.

Responsibilities

• Provide technical support and ensure operations comply with corporate/government policies and regulations in a cost-effective way and within customer timelines.
• Perform documentation activities per project assignment and customer requirements and comply with cGMP and safety procedures.
• Review SOPs, Work Instructions and forms to comply with ISO 17025:2017.
• Maintain client communication and monitor project status to meet client requirements.
• Promote positive client relationships and transparent, professional conduct at all times.
• Identify project opportunities by providing technical expertise and alert management to issues.
• Fulfill MTG administrative requirements (time sheets, CV updates, etc.).
• Stay informed on regulatory changes affecting validation in pharmaceutical, biotech, and healthcare industries.

Skills

MS Office

Data organization

Analytical thinking

Typing skills

Education

BA in Business Administration

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.