Manufacturing Document Clerk

Mentor Technical Group (MTG)

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, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Position Overview

We are seeking an experienced Document Clerk to support our pharmaceutical and biotechnology clients by managing, organizing, and maintaining critical documentation in compliance with FDA, cGMP, and ISO standards. This role ensures accuracy, accessibility, and regulatory compliance of all records, contributing to efficient quality and operational processes across projects.

Key Responsibilities

• Partner with Quality Assurance and Regulatory Affairs teams to manage controlled documents.
• Maintain electronic and physical document control systems, ensuring proper versioning, access, and security.
• Receive, log, and organize all incoming and outgoing documentation related to production, quality, and regulatory processes.
• Prepare, review, and distribute controlled documents, including SOPs, batch records, validation protocols, and regulatory submissions.
• Support audits and inspections by providing accurate and timely retrieval of documentation.
• Track document revisions, approvals, and expiration dates to ensure records remain current.
• Coordinate with cross-functional teams to facilitate timely submission, review, and approval of documents.
• Generate reports and metrics to support management oversight and quality monitoring.
• Ensure strict compliance with company policies, cGMP, FDA, and ISO requirements.

Qualifications & Requirements

• Associate's degree or higher in Life Sciences, Business Administration, or a related field.
• 25 years of experience in document control or clerical support in a regulated pharmaceutical or biotech environment.
• Knowledge of cGMP, FDA, and ISO documentation standards.
• Proficiency with electronic Document Management Systems (eDMS) and Microsoft Office Suite.
• Strong organizational skills with exceptional attention to detail.
• Excellent communication, teamwork, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced, regulated environment.

Preferred Qualifications

• Experience with eDMS systems such as Veeva Vault or MasterControl.
• Exposure to regulatory submissions, validation documentation, or quality audits.
• Knowledge of pharmaceutical manufacturing processes and lifecycle documentation.
• Demonstrated ability to maintain confidentiality and handle sensitive information.

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.