Document Controller

Mentor Technical Group • Manati, PR • 2w ago

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.

Similar Jobs

Manufacturing Coordinator

Adecco US, Inc. • Vega Baja, PR • 1h ago

Manufacturing & Warehouse

Adecco está asistiendo una industria electrónica con el reclutamiento de un Coordinador de Manufactura ubicado en Vega Baja. Esta es una oportunidad de asignación temp to hire. ¡Aplicar ahora si usted cumple con las cali...

1h ago

Go to Apply

Manufacturing Coordinator 2nd Shift

Adecco US, Inc. • Vega Baja, PR • 1h ago

Manufacturing & Warehouse

1h ago

Go to Apply

Commercial Sales Manager

AutoZone, Inc. • Manati, PR • 2d ago

Management & Administrative

The Commercial Sales Manager is responsible for driving the commercial sales within their AutoZone location. The CSM develops and maintains positive relationships with commercial customers by managing the acquisition and...

2d ago

Go to Apply

Construction Labor

Mentor Technical Group • Vega Baja, PR • 4d ago

Trucking & Construction

4d ago

Go to Apply

Join Our Talent Pipeline for Manufacturing Supervisors

AbbVie • Barceloneta, PR • 1w ago

Manufacturing & Warehouse

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable imp...

1w ago

Go to Apply

Lab Equipment Qualification (C&Q)

Mentor Technical Group • Manati, PR • 1w ago

1w ago

Go to Apply

Southeast Asian Restaurant Chef de Cuisine

Marriott • Dorado, PR • 1w ago

Retail & Hospitality

Additional Information Relocation assistance provided. Bonus eligible. Work visa sponsorship available. Job Number 25117010 Job Category Food and Beverage & Culinary Location Dorado Beach a Ritz-Carlton Reserve, 100...

1w ago

Go to Apply

Customer Service Associate

Walgreens • Dorado, PR • 1w ago

Management & Administrative

Job Description: Models and delivers a distinctive and delightful customer experience. Registers sales on assigned cash register, provides customers with courteous, fair, friendly, and efficient checkout service. Custome...

1w ago

Go to Apply

Omakase Specialty Restaurant Chef

Marriott • Dorado, PR • 1w ago

Retail & Hospitality

Additional Information Omakase Specialty Chef Job Number 25117018 Job Category Food and Beverage & Culinary Location Dorado Beach a Ritz-Carlton Reserve, 100 Dorado Beach Drive, Dorado, Puerto Rico, United States, 00...

1w ago

Go to Apply

Luxury Resort Restaurant Host-Hostess

Marriott • Dorado, PR • 3w ago

Retail & Hospitality

Additional Information Luxury Resort Pool & Beach Host-Hostess Job Number 25111543 Job Category Food and Beverage & Culinary Location Dorado Beach a Ritz-Carlton Reserve, 100 Dorado Beach Drive, Dorado, Puerto Ri...

3w ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.