Technical Writer – Deviation Investigations
Key Responsibilities
- Write, document, and maintain deviation investigations related to manufacturing, quality, equipment, materials, and laboratory processes.
- Gather information from Manufacturing, Quality Assurance, QC, Engineering, and other departments to support investigations.
- Document root-cause investigations, impact assessments, and investigation conclusions.
- Review batch records, SOPs, production records, test results, equipment logs, and other GMP documentation.
- Ensure investigation reports are accurate, complete, clear, and compliant with cGMP and FDA requirements.
- Assist with identifying and documenting CAPAs, corrective actions, and preventive actions.
- Track investigation timelines and ensure documentation is completed within required deadlines.
- Edit technical content for clarity, consistency, grammar, and regulatory compliance.
- Identify documentation gaps or inconsistencies and work with SMEs to obtain missing information.
- Support change controls, CAPAs, nonconformances, and other quality-system documentation as needed.
- 2+ years of technical writing, quality documentation, or GMP documentation experience.
- Experience writing or supporting deviation investigations.
- Knowledge of cGMP, FDA regulations, SOPs, CAPA, and change controls.
- Experience working in biopharma, pharmaceutical, medical device, or other regulated manufacturing.
- Strong ability to analyze information and turn technical findings into a clear, organized investigation report.
- Strong attention to detail and written communication skills.
