Documentation Specialist

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. 

Under general supervision, the Environmental Monitoring and Sampling Technician will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations. 

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
• Contribute to team efforts by accomplishing business results as needed
• Performs other related duties and special projects as assigned or directed
• Should have good people skills with all levels of technical and operations personnel
• Ability to complete position requirements with limited direct supervision
• Ability to gather, organize information and ability to handle a variety of projects at the same time
• Ability to grasp technical terms, processes and methods
• Should have Microsoft office skills, administrative writing skills and reporting skills
• Demonstrate ability to complete assignments that are accurate, neat and error-free, containing proper format, syntax, spelling, punctuation and grammar
• Must be bilingual (English/Spanish) and must have good communication skills both oral and written
• 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.
• Must possess excellent organization and communication skills both verbal and written in Spanish and English

Qualifications Requirements/Knowledge/Education/Skills: 

• 0-2 years minimum of controls or test and balance experience or mechanical design Bachelor in Science or Engineering degree from an Accredited University Proficient with Microsoft Office suite including Word, Excel, Outlook, power point Experienced in controls, test & balance and/or design Fast learner

• Knowledge in GMP's and SOP's