Compliance Documentation Specialist

Compliance Documentation Specialist

Job Summary

We are seeking a detail-oriented Compliance Documentation Specialist with experience in document control, quality systems, and compliance governance within regulated environments. The role is responsible for managing controlled documentation, ensuring compliance with Good Documentation Practices (GDP), Quality Management System (QMS) requirements, and organizational standards while supporting audit readiness and operational excellence.

Key Responsibilities

• Create, review, update, and maintain controlled documents including SOPs, policies, standards, work instructions, templates, and compliance records.
• Manage document lifecycle activities including review, approval, version control, change management, and periodic assessments.
• Collaborate with Quality, Compliance, Engineering, Information Security, and business stakeholders to document processes and controls.
• Ensure documentation remains accurate, traceable, audit-ready, and aligned with GDP and document governance standards.
• Maintain document repositories and controlled document management systems.
• Support internal and external audits through documentation readiness and compliance evidence management.
• Convert complex technical and operational processes into clear, structured, and user-friendly documentation.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Technology, Quality Management, or a related field.
• 5+ years of experience in compliance documentation, document control, quality systems, validation, governance, or regulated environments.
• Strong experience authoring and managing SOPs, policies, standards, templates, and work instructions.
• Sound understanding of document lifecycle management, change control, version management, and approval workflows.
• Excellent technical writing, editing, proofreading, and organizational skills.
• Working knowledge of SDLC concepts and experience collaborating with cross-functional stakeholders.
• Proficiency in Microsoft Office, SharePoint, and document management platforms.

Preferred Qualifications

• Experience with QMS, ISMS, GxP, CSV, CSA, Software Quality, or similar regulated environments.
• Knowledge of ISO 9001:2015 and/or ISO/IEC 27001 standards.
• Familiarity with risk assessments, traceability frameworks, validation processes, and audit support activities.
• Experience with electronic document management systems and controlled repositories.
• Exposure to AI, automation, analytics, and emerging technology governance documentation.

Preferred Certifications

• ISO 9001:2015 Internal/Lead Auditor
• ISO/IEC 27001 Internal/Lead Auditor
• ASQ Certifications (CQA, CMQ/OE)
• Compliance, Validation, Document Control, or Project Management Certifications

Skills: Compliance Documentation, Document Control, SOP Development, QMS, GDP, Audit Support, Technical Writing, Change Management, SDLC, ISO 9001, ISO 27001, SharePoint, Governance, Quality Assurance, Information Security.