Document Controller
Document Controller
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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 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:
- Author revise and maintain SOPsand related controlled documents in accordance with regulatory and company standards.
- Collaborate with cross-functional teams(e.g. QA QC Manufacturing R&D Regulatory) to gather process information and ensure SOPs reflect current practices.
- Ensure SOPs are clear concise and user-friendly enabling consistent execution by staff.
- Manage document lifecycleusing electronic document management systems (EDMS) including version control approvals and archival.
- Support internal and external auditsby ensuring documentation is inspection-ready.
- Train staffon new or revised SOPs and maintain training records.
- Continuously improve documentation practicesto enhance clarity compliance and usability.
Qualifications Requirements/Knowledge/Education/Skills:
- Education:Bachelors degree in Life Sciences Engineering Technical Writing or related field.
- Experience:25 years in a regulated industry (pharma biotech medical devices) with direct experience in SOP writing or quality documentation.
- Knowledge of regulationssuch as FDA 21 CFR Part 11 ISO 13485 ICH Q10 and GxP principles.
- Proficiency in EDMS(e.g. Veeva CDOCS Kneat AMLMasterControl Documentum).
- Strong writing and editing skills with the ability to translate complex processes into clear instructions.
- Attention to detailand strong organizational skills.
- Excellent communication and interpersonal skillsfor cross-functio
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica 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.
Required Experience:
Manager
Employment Type
Full-Time
