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.
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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.
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