Job Information
Mentor Technical Group Documentation Specialist Engineer in Juncos, Puerto Rico
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:
Translate documents as required, ensuring that the meaning of the source text is retained. Write, edit and maintain documentation in a controlled fashion.
Collaborate with responsible personnel and areas experts to gain an understanding of the technical terms and process/product requirements.
Research legal, technical and scientific phraseology to find the correct translation. Ensure accuracy and completeness of technical and operational translated documentation
Use the appropriate technology such as internet, email, as research tools throughout the translation process.
Coordinate, track, log and control the translation activities to meet deadlines, while providing support and guidance to requesters
Support Document Control Department activities such as managing, distribution, typing and archiving controlled documents
Support product transfer activities in the handling and translation of documents
Provides frequent assistance in person or over the telephone, which requires a high degree of tact and technical knowledge to internal and external customers
Serves a liaison between facilities regarding document changes and other matters
Responsible for follow-up on actions and commitments, to ensure that decisions are implemented and appropriate parties are notified
Meeting with clients to discuss the document and clients’ needs
Proof reading and editing documents for accuracy, correctness, completeness, grammar verification and adherence to Bard policies
Comply with cGMP’s, ISO and other regulatory requirements applicable to Bard operations
Maintain professional and technical knowledge
Teamwork oriented
Must possess excellent organization and communication skills both verbal and written in Spanish and English
Knowledge of QSR and ISO, excellent computer skills, auditing and reporting skills
Demonstrated capabilities with the use of PC and MS Office applications such as Excel and Word
Must handle matters independently based on skills, knowledge of issues and prior directions
Must have good independent judgment and a demonstrated ability to set priorities
Be able to maintain multiple ongoing tasks on a tight deadline and work at a fast pace
Work cooperatively with co-workers and management
Ability to effectively deal with a wide variety of internal and external customers from executive staff to manufacturing/operations employees
Ability to work in a cross-functional team environment, as well as the ability to function independently
Prior experience in documentation control systems preferred.
Education and Skills:
Bachelor's in Science or Engineering degree and 3 years of experience.
Knowledge in GMP's and SOP's
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.
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