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.

Qualifications:

· 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.