Regulated Documents Specialist - Life Sciences

Mentor Technical Group; Puerto Rico; On-site; USD 40,000 - 60,000; Full time

Job summary

A leading technical solutions provider in the United States is seeking a Document Clerk to manage, organize, and maintain critical documentation in compliance with FDA and ISO standards. The role involves ensuring accuracy and accessibility of records while contributing to quality processes. Ideal candidates will have an Associate’s degree and 2-5 years in a regulated environment, along with strong organizational and communication skills. This position is essential for supporting quality assurance and regulatory compliance across projects.

Qualifications

• 2–5 years of experience in document control or clerical support in a regulated pharmaceutical or biotech environment.
• Knowledge of cGMP, FDA, and ISO documentation standards.
• Strong ability to manage multiple priorities in a fast-paced, regulated environment.

Responsibilities

• Partner with Quality Assurance and Regulatory Affairs teams to manage controlled documents.
• Maintain electronic and physical document control systems.
• Prepare, review, and distribute controlled documents.

Skills

Organizational skills

Attention to detail

Communication skills

Teamwork

Problem-solving

Education

Associate’s degree or higher in Life Sciences, Business Administration, or related field

Tools

Electronic Document Management Systems (eDMS)

Microsoft Office Suite

Job description

A leading technical solutions provider in the United States is seeking a Document Clerk to manage, organize, and maintain critical documentation in compliance with FDA and ISO standards. The role involves ensuring accuracy and accessibility of records while contributing to quality processes. Ideal candidates will have an Associate’s degree and 2-5 years in a regulated environment, along with strong organizational and communication skills. This position is essential for supporting quality assurance and regulatory compliance across projects.