Documentation Specialist (Regulated Industry

Title: Documentation Specialist (Regulated Industry) Location: Puerto Rico Work Model: 100% Remote Positions: 1

Overview

Our client is seeking an experienced Documentation Specialist with strong proficiency in controlled documentation management, technical writing, and quality systems data entry. The ideal candidate will support the creation, revision, formatting, and control of documentation within a regulated environment, ensuring compliance with internal procedures, industry standards, and applicable regulatory requirements. This role requires a highly organized professional with excellent writing skills, strong attention to detail, and a solid understanding of documentation workflows within FDA-regulated or similarly regulated industries.

Key Responsibilities

Controlled Documentation & Technical Writing

• Create, revise, and maintain controlled documents including SOPs, work instructions, specifications, batch records, forms, templates, risk assessments, validation documents, and supporting materials.
• Prepare and update validation documentation such as protocols (IQ/OQ/PQ), reports, traceability matrices, and summary documents.
• Draft and maintain risk assessment documentation (FMEA, hazard analyses, impact assessments, etc.) ensuring alignment with regulatory expectations.
• Ensure all documentation meets procedural, regulatory, and formatting requirements.
• Translate complex technical information into clear, concise, and compliant documentation.
• Collaborate with subject matter experts to gather content, verify accuracy, and implement updates or revisions.

Quality Systems Documentation

• Perform documentation data entry within Quality Management Systems (QMS), including document control modules, change control systems, training records, and CAPA/Deviation documentation, as applicable.
• Manage full document lifecycle: drafting, routing, reviewing, approving, issuing, archiving, and retiring documents.
• Support internal and external audits or regulatory inspections by preparing documentation, records, and evidence packages.
• Maintain version control, controlled distribution lists, document metadata, and traceability throughout the lifecycle.

Compliance & Regulatory Alignment

• Ensure all documentation complies with applicable regulatory and industry standards (GMP, GLP, GCP, ICH, FDA, ISO, etc.).
• Evaluate documentation-related gaps and recommend improvements to strengthen compliance and document quality.
• Maintain adherence to data integrity principles, including ALCOA+ standards for accuracy, legibility, and traceability.

Cross-Functional Collaboration

• Collaborate with QA, Manufacturing, Validation, Operations, Laboratory, Engineering, and Technical Services teams to ensure documentation alignment, accuracy, and timely completion.
• Provide documentation guidance, best practices, and training to cross-functional partners when needed.

Additional Responsibilities

• Support process improvement initiatives related to documentation workflows, templates, formatting standards, and compliance enhancements.
• Perform other documentation-related duties as needed to support departmental and organizational goals.

Required Qualifications

• Bachelor’s degree in Science, Engineering, Technical Writing, Quality, or a related field.
• Minimum 5 years of experience in documentation writing within FDA-regulated or similarly regulated industries (pharmaceutical, biotechnology, medical device, chemical, etc.).
• Strong understanding of document control systems, controlled documentation workflows, and QMS processes.
• Demonstrated experience writing and formatting validation documents and risk assessment documentation.
• High proficiency in Microsoft Office (Word, Excel, PowerPoint) and electronic documentation/QMS platforms.
• Excellent written and verbal communication skills with strong attention to detail.
• Solid knowledge of GMP, data integrity principles, and regulatory compliance requirements.
• Ability to manage multiple priorities and deliver high-quality work in a remote environment.

Preferred Qualifications

• Experience with platforms such as Veeva, MasterControl, TrackWise, Documentum, or other QMS/document control systems.
• Experience supporting audits, regulatory inspections, and documentation readiness activities.
• Bilingual (English/Spanish) preferred.

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