Documentation Technician

Mentor Technical Group; Carolina (PR); On-site; USD 45,000 - 65,000; Full time

Job summary

Mentor Technical Group, a leading provider of life sciences engineering solutions, seeks a documentation control professional to support electronic documentation systems and cGMP compliance in a regulatory setting. This role focuses on document control, release of controlled documents, and data integrity across projects.

Strong communication and bilingual English/Spanish skills are required. Ideal candidates will manage multiple documents, generate periodic reports, and collaborate with

Qualifications

• Proficient in documenting processes and records.
• Ability to audit, record-check and identify deviations.
• Must be bilingual (English/Spanish) with strong written and spoken communication.
• Ability to manage multiple projects and organize information.

Responsibilities

• Manages documentation store activities and supports electronic documentation system.
• Administers document release and controlled documents issuance.

Skills

People skills

Record checks

Bilingual EN/ES

Information gathering

MS Office proficiency

Auditing

Report preparation

Teamwork

Training compliance

PPE & safety

cGMP compliance

Tools

Windows MS Office

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, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities

• Participates and support all activities related with documentation store, supply, etc
• Administers the electronic documentation system (check in, document/CRs release, and controlled documents issuance)

Qualifications Requirements/Knowledge/Education/Skills

• Should have good people skills with all levels of technical and operations personnel
• Ability to record-check and identify deviations, as well as have initiative to track corrective actions
• Must be bilingual (English/Spanish) and have good communication skills both orally and in writing
• Ability to gather, organize information and ability to handle a variety of projects at the same time
• Must possess computerized system skills such as Windows MS Office (Word, Excel, Power Point, among others)
• Ability to inspect, audit, organize, interpret, read, copy, memorize and document
• Teamwork oriented
• Prepare periodic reports as required
• Maintains professional and technical knowledge
• Contributes to team efforts by accomplishing business results as needed
• Assures is trained before performing any task
• Uses the required clothes, personal and security protective equipment according to the requirements of its operation
• Complies with cGMP’s, Quality Standards and established policies and/or procedures

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.