Senior Technical Writer

Senior Technical Writer position in Quality Control at Johnson & Johnson's Titusville facility. Leads GMP document creation and laboratory investigations in stability operations, ensuring compliance with regulatory standards. Requires QC laboratory experience, advanced technical writing skills, and expertise in analytical instrumentation.

Responsibilities

• Plan, execute, and write laboratory investigations with root cause analysis and corrective/preventative actions
• Develop and edit SOPs, validation protocols, analytical documents, and technical reports from concept through implementation
• Conduct gap assessments of technical documentation to ensure current standards and optimal process functioning
• Mentor new investigation writers and lab analysts on technical writing best practices
• Support Health Authority inspections as subject matter expert and contribute to continuous improvement initiatives

Requirements

• Detailed knowledge of analytical laboratory technologies (HPLC, Dissolution, IR, Karl Fischer)
• Prior experience working as QC laboratory bench analyst
• Demonstrated proficiency with root cause analysis tools (Kepner-Tregoe, Fishbone, 5-Why)
• Advanced technical writing and strong communication skills with attention to detail
• Thorough understanding of current Good Manufacturing Practices (cGMP) for QC environments
• Experience with quality management systems (Trackwise, COMET, Docspace, TruVault, eLIMS or equivalent)
• Proficiency with Microsoft Office applications and ability to work independently

Compensation: $79,000–$127,650 base