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 SOPs and 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 lifecycle using electronic document management systems (EDMS), including version control, approvals, and archival.
- Support internal and external audits by ensuring documentation is inspection-ready.
- Train staff on new or revised SOPs and maintain training records.
- Continuously improve documentation practices to enhance clarity, compliance, and usability.
Qualifications Requirements/Knowledge/Education/Skills:
- Education: Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field.
- Experience: 2–5 years in a regulated industry (pharma, biotech, medical devices) with direct experience in SOP writing or quality documentation.
- Knowledge of regulations such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and GxP principles.
- Proficiency in EDMS (e.g., Veeva, CDOCS, Kneat, AML, MasterControl, Documentum).
- Strong writing and editing skills, with the ability to translate complex processes into clear instructions.
- Attention to detail and strong organizational skills.
- Excellent communication and interpersonal skills for cross-functio
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.
