QC Deviation Writer

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).

• 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 reports.
• Collaborate 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.

• 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 environment.
• Knowledge of pharmaceutical, biopharmaceutical, or biotechnology manufacturing processes.
• Experience with root cause analysis methodologies and CAPA development.
• Strong written communication and technical documentation skills.
• Familiarity with electronic Quality Management Systems (eQMS) and document management systems.
• Proficiency with Microsoft Word, Excel, and other Microsoft Office applications.

• Experience supporting manufacturing investigations in pharmaceutical or biotech facilities.
• Understanding of GMP regulations and quality compliance requirements.
• Strong organizational skills with exceptional attention to detail.
• Ability to work independently while collaborating effectively with cross-functional teams.