Documentation Specialist

Mentor Technical Group; Barcelona; Presencial; EUR 32.000 - 52.000; Jornada completa

Descripción de la vacante

Mentor Technical Group seeks a detail-oriented Documentation Specialist to support cGMP-compliant activities for pharmaceutical and life sciences projects. You will manage technical documentation, ensure regulatory compliance, and contribute to ISO 17025:2017 standards while collaborating with MTG teams to meet client expectations.

Responsibilities include maintaining quality records, reviewing procedures, and supporting audits; you will also coordinate with supervisors to ensure timely delivery

Formación

• BA in Business Administration is required.
• Proficient in common software (word processing, spreadsheets, databases).
• Basic analytical experience is needed.
• Proficient typing skills expected.
• Data organization and storage knowledge is desired.

Responsabilidades

• Perform documentation activities with direct supervision and in line with cGMP and Safety procedures.
• Provide technical support to ensure activities comply with policies and regulations and timelines.
• Review SOPs, Work Instructions and Forms to align with ISO 17025:2017.
• Maintain proactive client communication and MTG relationships.
• Ensure quality of deliverables and monitor project status against client requirements.

Conocimientos

Documentation management

Regulatory compliance

Client communication

Quality assurance

Educación

BA in Business Administration

Herramientas

MS Word

MS Excel

Databases

Descripción del empleo

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 the Pharmaceutical, 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.