Documentation Specialist | On Site | Barceloneta, PR

Job DescriptionJob DescriptionJob OverviewWe are seeking a highly detail-oriented Documentation Specialist to support a critical project involving the implementation of Electronic Batch Records (EBR) within a SmartForms and Document Management system. This role will focus on reviewing, editing, and refining controlled documentation (SOPs, forms, procedures) to ensure clarity, consistency, and compliance within a regulated environment.The ideal candidate will play a key role in transforming complex technical content into structured, accurate, and user-friendly documentation, supporting biologics manufacturing processes and ensuring alignment with quality and operational standards.Main ResponsibilitiesReview, edit, and standardize controlled documents including SOPs, forms, and work instructions.Support documentation activities related to Electronic Batch Record (EBR) implementation.Ensure documentation is clear, concise, and aligned with process requirements and regulatory standards.Refine technical content to improve readability, consistency, and structure.Format and organize documents using Microsoft Word and document management systems.Collaborate with Subject Matter Experts (SMEs) to clarify technical content and ensure accuracy.Support migration from paper-based documentation to electronic systems (SmartForms).Maintain document control, versioning, and traceability.Identify gaps, inconsistencies, or unclear content and propose improvements.Ensure SOP language is precise and compliant with quality standards.General RequirementsStrong Microsoft Word skills (formatting, editing, document structuring).Ability to use AI tools or systems to enhance document clarity, structure, and formatting consistency.Excellent written communication skills with the ability to simplify complex information.Strong attention to detail and commitment to accuracy.Ability to review and refine technical content for clarity and readability.Comfortable working with complex technical documentation in regulated environments.Strong collaboration and communication skills to work effectively with cross-functional teams and SMEsEducationBachelor’s degree in Life Sciences, Engineering, Technical Writing, or a related field preferred.Equivalent experience in regulated industries will be considered.Experience3+ years of experience in document control, technical writing, or quality documentation in regulated industries (pharmaceutical, biotech, or manufacturing).Experience working with SOPs, batch records, or controlled documentation.Exposure to Electronic Document Management Systems (EDMS) or EBR systems is preferred.Experience supporting biologics processes, especially monoclonal antibody manufacturing, is a strong plus.Experience working in GMP-regulated environments preferred.Physical RequirementsProlonged periods of sitting and working on a computer.Ability to review detailed documents for extended periods.Occasional collaboration in office or operational environments as needed.