Deviation Writer

Job Title: Deviation WriterLocation: Bloomington, INPosition Overview:We are seeking motivated and detail-oriented Deviation Writers with 2–4 years of experience in GMP-regulated environments to support investigation and documentation activities within pharmaceutical, biotechnology, or life sciences manufacturing operations. This role is responsible for authoring deviation investigations, identifying root causes, and collaborating with cross-functional teams to ensure effective corrective and preventive actions (CAPAs.Key Responsibilities:Investigate and author deviation reports, non-conformances, and manufacturing events in partnership with Subject Matter Experts (SMEs)Gather facts, analyze data, review documentation, and evaluate evidence to support investigation conclusions.Perform root cause analysis using tools such as 5 Whys, Fishbone (Ishikawa), and other problem-solving methodologies.Develop robust corrective and preventive actions (CAPAs) to prevent recurrence of quality events.Translate complex technical issues into clear, concise, and compliant investigation reportCollaborate with Manufacturing, Engineering, MS&T, Supply Chain, Quality, and other departments throughout the investigation process.Review historical deviations and trends to identify recurring issues and improvement opportunities.Ensure investigations are completed in accordance with GMP requirements and internal quality procedures.Qualifications:Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline.2–4 years of experience in deviation writing, technical writing, investigations, or quality systems within a GMP-regulated environments.Knowledge of pharmaceutical, biopharmaceutical, or biotechnology manufacturing processExperience with root cause analysis methodologies and CAPA developmentsStrong written communication and technical documentation skills.Familiarity with electronic Quality Management Systems (eQMS) and document management systemsProficiency with Microsoft Word, Excel, and other Microsoft Office applications