Deviation Investigations Specialist

Responsibilities:

• Lead and co-author cGMP investigations for OSD manufacturing, including deviations, nonconformances, and atypical events.
• Ensure clear problem statements, accurate timelines, and timely closure of investigations within the quality system.
• Coordinate event triage, containment actions, and escalation while supporting batch disposition decisions.
• Collect, organize, and analyze data from manufacturing, engineering, and laboratory sources such as batch records, equipment logs, MES, SCADA, and test results.
• Establish event sequences and identify contributing factors through detailed data analysis.
• Facilitate root cause analysis using structured methodologies such as 5-Why, fishbone, and fault tree analysis.
• Document technically sound conclusions and perform product impact assessments.
• Define, implement, and track CAPAs, including corrective and preventive actions with effectiveness checks.
• Support on-the-floor verification and ensure implementation of corrective actions to prevent recurrence.
• Prepare and maintain complete investigation and CAPA documentation in compliance with regulatory standards.
• Support trending, continuous improvement initiatives, and audit/inspection readiness activities.
• Provide documentation, evidence packages, and responses during audits and inspections.

Required Skills And Experience:

• Master s or Ph.D. degree or equivalent combination of education, training, and experience.
• Strong knowledge of OSD manufacturing processes such as blending, granulation, compression, coating, and encapsulation.
• Experience with cGMP regulations, pharmaceutical quality systems, and data integrity requirements.
• Proficiency in root cause analysis tools such as 5-Why, fishbone, and fault tree analysis.
• Experience using electronic quality and data systems such as eQMS, MES, LIMS, and historian tools.
• Strong analytical skills with the ability to interpret and trend manufacturing, equipment, and laboratory data.
• Ability to manage multiple investigations and work cross-functionally with stakeholders.
• Strong written and verbal communication skills to present complex technical information clearly.
• Proficiency in Microsoft Office tools, especially Excel for data analysis and reporting.

Preferred Qualifications:

• Experience with AI tools and advanced data analysis platforms for investigation and trending.
• Prior experience supporting regulatory audits and inspections.
• Strong understanding of CAPA management and effectiveness monitoring.
• Experience working in pharmaceutical or life sciences manufacturing environments.

Problem Solving And Competencies:

• Ability to independently handle moderate to complex problems involving multiple variables and data sources.
• Strong critical thinking and decision-making skills to identify root causes and implement effective solutions.
• Proactive approach to recommending and implementing process improvements.
• Collaborative mindset to solve problems through teamwork and cross-functional engagement.