Job Title: Deviation Writer
Location: Bloomington, IN
Position 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 Responsibilitie
- s:Investigate and author deviation reports, non-conformances, and manufacturing events in partnership with Subject Matter Experts (SME
- s)Gather facts, analyze data, review documentation, and evaluate evidence to support investigation conclusion
- s.Perform root cause analysis using tools such as 5 Whys, Fishbone (Ishikawa), and other problem-solving methodologie
- s.Develop robust corrective and preventive actions (CAPAs) to prevent recurrence of quality event
- s.Translate complex technical issues into clear, concise, and compliant investigation repo
- rtCollaborate with Manufacturing, Engineering, MS&T, Supply Chain, Quality, and other departments throughout the investigation proces
- s.Review historical deviations and trends to identify recurring issues and improvement opportunitie
- s.Ensure investigations are completed in accordance with GMP requirements and internal quality procedure
s.
Qualificatio
- ns:Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipli
- ne.2–4 years of experience in deviation writing, technical writing, investigations, or quality systems within a GMP-regulated environmen
- ts.Knowledge of pharmaceutical, biopharmaceutical, or biotechnology manufacturing proc
- essExperience with root cause analysis methodologies and CAPA developme
- ntsStrong written communication and technical documentation skil
- ls.Familiarity with electronic Quality Management Systems (eQMS) and document management syst
- emsProficiency with Microsoft Word, Excel, and other Microsoft Office applicati