Deviation Investigations Specialist

Deviation Investigations Specialist

This position is responsible for leading and performing cGMP investigations supporting Oral Solid Dose (OSD) manufacturing, including complex manufacturing processes and equipment. The Investigator I authors and coordinates high-quality investigations for events occurring in Production, Engineering, Quality Control (QC) Laboratory, and related support areas, ensuring timely root cause identification, appropriate product impact assessments, and implementation of effective Corrective and Preventive Actions (CAPAs) to maintain compliant supply.

The role applies scientific and technical judgment to evaluate manufacturing and laboratory data, interviews and observation, equipment/utilities performance, and process parameters to support robust root cause analysis and sustainable remediation for OSD unit operations (e.g., blending, granulation, compression, coating, encapsulation, etc.) and associated systems.

Core Requirements:

• Minimum 2 years of pharmaceutical industry experience in Deviation Investigations
• Experience in Deviation Investigations, CAPAs, and FDA audit exposure
• Strong cross-functional collaboration, negotiation, and communication skills
• Ability to proactively engage stakeholders and navigate complex investigations
• Minimum Master's degree

Essential Responsibilities:

• Lead and/or co-author cGMP investigations for OSD manufacturing and complex operations (deviations/nonconformances/atypical events), ensuring clear problem statements, accurate timelines, and timely closure in the quality system
• Coordinate event triage and immediate actions, including containment and escalation, and support batch disposition decisions with Operations, Engineering, QC, and QA
• Collect, organize, and analyze manufacturing, engineering, and laboratory evidence (e.g., batch records, equipment/maintenance logs, MES/SCADA/historian data, calibrations, environmental monitoring, and test results) to establish event sequence and contributing factors
• Facilitate cross-functional root cause analysis using structured tools (e.g., 5-Why, fishbone, fault tree as applicable) and document technically sound, compliant conclusions and product impact assessments
• Define, document, and track CAPAs (correction/corrective/preventive actions) with appropriate due dates and effectiveness checks; support on-the-floor verification and implementation to prevent recurrence
• Prepare clear, complete investigation/CAPA records; support trending and continuous improvement; and participate in audit/inspection readiness by providing evidence packages and responses while maintaining required training and safe work practices

Education & Experience:

• Master's or Ph.D. degree in a scientific or engineering discipline
• Relevant experience supporting investigations within pharmaceutical manufacturing, engineering, and/or QC laboratories
• Oral Solid Dosage (OSD) experience preferred
• Experience using electronic quality systems and manufacturing/laboratory data systems (e.g., deviation/CAPA systems, MES, LIMS, historian/trending tools, AI tools) preferred

Required Skills & Knowledge:

• OSD manufacturing and complex process/equipment knowledge sufficient to investigate events across Production, Engineering, and QC (e.g., blending, granulation, compression, coating, encapsulation, and supporting utilities)
• Strong technical writing and documentation skills (deviations/nonconformances, OOS/OOT as applicable, product impact assessments, CAPA, and effectiveness checks) using Good Documentation Practices (GDP)
• Knowledge of cGMP, pharmaceutical quality systems, and data integrity expectations applicable to investigations, CAPA, and inspection readiness
• Analytical and problem-solving capability using structured root cause analysis tools (e.g., 5-Why, fishbone, fault tree)
• Ability to interpret and trend manufacturing/equipment/lab data using available systems and tools (e.g., eQMS, MES, LIMS, historian/trending tools, Excel/dashboards)
• Effective cross-functional facilitation and communication skills, including managing multiple investigations, aligning stakeholders, and presenting complex technical information clearly

Problem Solving:

• Works on problems of moderate to complex scope requiring analysis of contributing factors and evaluation of known and unknown variables
• Selects appropriate methods and techniques for obtaining results
• Recommends and administers methods and procedures for problem resolution
• Identifies solutions through collaboration and creativity

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).