Deviation Writer

Responsibilities:

• Lead the investigation and documentation of nonconforming events and process deviations across multiple departments including manufacturing, engineering, quality, and supply chain.
• Partner with subject matter experts to gather relevant information, data, and supporting evidence needed for thorough root cause analysis.
• Utilize structured problem-solving tools to identify true root causes and recommend robust corrective and preventative actions (CAPAs).
• Translate technical findings and complex operational scenarios into clear, concise, and well-structured investigation reports.
• Drive the use of automation and engineering controls as part of continuous improvement and risk mitigation strategies.
• Collaborate cross-functionally to ensure investigation content is accurate, logical, and representative of operational facts.
• Analyze historical deviations and non-conformance data to detect trends and proactively prevent recurrence.
• Contribute to a culture of compliance and quality by ensuring all documentation meets regulatory and internal standards.

Qualifications:

• Bachelor’s degree in a life sciences, engineering, or related technical field.
• Minimum of 3 years of experience in a technical writing or deviation investigation role within a GMP-regulated manufacturing environment.
• Strong understanding of pharmaceutical or biotech production processes and associated regulatory requirements.
• Demonstrated ability to write clear, fact-based, and audit-ready investigation documents.
• Effective communicator capable of working across technical and non-technical teams.
• Skilled in root cause analysis tools and quality risk management principles.
• Proficient in Microsoft Word and Excel; experience with electronic document management systems is preferred.
• Detail-oriented, organized, and capable of managing multiple investigations simultaneously while meeting deadlines.