Deviation Writer

Job Responsibilities

• Author detailed deviation investigations and nonconformance reports across multiple technical areas in collaboration with Subject Matter Experts (SMEs).
• Gather and analyze data, interpret technical findings, and synthesize information into clear, defensible investigative documentation.
• Apply structured root cause methodologies such as 5 Whys, Ishikawa/Fishbone diagrams, and other analytical tools.
• Develop robust corrective and preventive actions (CAPA), leveraging engineering controls, automation, and error-proofing strategies where appropriate.
• Translate complex manufacturing processes and technical descriptions into concise, compliant, and audit-ready documentation.
• Collaborate with internal stakeholders to ensure investigations logically represent factual evidence and align with regulatory expectations.
• Evaluate historical deviations, non-conformances, and adverse trends to identify recurring issues and implement preventative strategies.
• Ensure documentation meets GMP requirements and supports inspection readiness.

• Bachelor’s degree in a scientific, engineering, or technical discipline required.
• Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably within pharmaceutical, biopharmaceutical, or biotechnology manufacturing.
• Demonstrated expertise in writing clear, concise, and technically accurate investigation reports.