Documentation Specialist On Site Barceloneta, PR

Job Description

Job Overview

We are seeking a detail-oriented Documentation Specialist to support a project focused on the implementation and management of Electronic Batch Records (EBR) within a SmartForms and Document Management system environment. This role will be responsible for reviewing, organizing, and ensuring the accuracy of controlled documentation such as procedures, forms, and related quality documents. The ideal candidate will support the transition from paper-based systems to an electronic document management platform, ensuring compliance, traceability, and data integrity.

Main Responsibilities

Review, edit, and validate controlled documents including SOPs, forms, and work instructions.

Support documentation activities related to Electronic Batch Record (EBR) implementation.

Ensure documents are accurate, complete, and compliant with internal quality standards and regulatory requirements.

Organize and maintain document control within SmartForms and Document Management systems.

Collaborate with cross-functional teams (Quality, Manufacturing, IT, Validation) to gather required inputs.

Support documentation migration from paper-based systems to electronic platforms.

Track document revisions, approvals, and version control.

Assist in audits by ensuring documentation readiness and traceability.

Identify inconsistencies or gaps in documentation and escalate as needed.

General Requirements

Strong attention to detail and organizational skills.

Ability to manage multiple documentation tasks and deadlines.

Familiarity with controlled document systems or quality management systems.

Strong communication skills to interact with cross-functional teams.

Proficiency in Microsoft Office (Word, Excel, PDF editing tools).

Ability to work independently and in a team environment.

Education

Bachelor’s degree in Science, Engineering, Business Administration, or related field (preferred).

Equivalent combination of education and relevant experience will be considered.

Experience

1–3 years of experience in documentation control, quality assurance, or administrative support in regulated environments (pharmaceutical, biotech, manufacturing, or similar preferred).

Experience working with controlled documents such as SOPs, forms, or batch records is highly desirable.

Exposure to Electronic Document Management Systems (EDMS) or EBR systems is a plus.

Physical Requirements

Ability to work in an office or hybrid environment.

Prolonged periods of sitting and working on a computer.

Occasional standing or walking within office or manufacturing areas if required.

Ability to review documents on screen for extended periods.