Documentation Specialist Engineer
hace 4 semanas
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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