Executive, Technical Writing

Essential Functions:

• Prepare, develop, and maintain technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
• Conduct periodic document audits to ensure ongoing compliance, traceability, and alignment with evolving regulatory requirements
• Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation
• Review existing documentation to identify gaps, inconsistencies, or areas requiring update and escalate findings to relevant stakeholders
• Ensure all technical documents accurately reflect manufacturing processes, equipment operations, and quality systems
• Support the document control lifecycle including creation, revision, review, approval, and archival of technical documents
• Maintain accurate and complete documentation records including document revision histories and change control logs
• Ensure all technical writing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements
• Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance
• Support training activities related to technical documentation standards and cGMP requirements as required.