Deviation Investigator

Contract Duration: 03 months with possible extension or conversion Job Summary: The MS&T Specialist I will support cGMP investigations within pharmaceutical oral solid dose manufacturing operations. This role will lead complex investigations, root cause analysis, product impact assessments, and CAPA activities across manufacturing, engineering, quality control, and related support functions. The position requires strong technical judgment, analytical problem solving, and the ability to evaluate manufacturing, equipment, laboratory, and process data. The successful candidate will work closely with cross functional teams to identify sustainable solutions and support compliant commercial manufacturing operations. The role also contributes to continuous improvement, process validation, technical troubleshooting, and inspection readiness activities. Key Responsibilities: Lead and coordinate cGMP investigations involving deviations, nonconformances, atypical events, and complex manufacturing operations. Coordinate event triage, containment, escalation, and immediate actions while supporting product disposition activities with Operations, Engineering, Quality Control, and Quality Assurance. Collect, organize, and analyze batch records, equipment records, maintenance information, laboratory results, process data, calibration records, environmental monitoring data, and other relevant evidence. Conduct structured root cause analysis using methods such as 5 Why, fishbone analysis, and fault tree analysis. Develop technically sound investigation conclusions, product impact assessments, corrective actions, preventive actions, and effectiveness checks. Prepare clear and compliant investigation and CAPA documentation using Good Documentation Practices. Analyze and trend manufacturing, equipment, and laboratory data to identify recurring issues and support risk based decisions. Collaborate with Manufacturing, Quality, Engineering, Regulatory, and other cross functional teams to resolve technical issues and prevent recurrence. Support continuous improvement, audit readiness, inspection readiness, and implementation of sustainable remediation activities. Required Qualifications: Master’s or PhD degree in Science, Engineering, or another relevant scientific discipline. Strong experience in pharmaceutical manufacturing, technical services, investigations, or a related GMP environment. Experience leading or supporting deviation investigations, root cause analysis, CAPA development, and technical problem solving. Strong understanding of cGMP requirements, pharmaceutical quality systems, data integrity, and regulatory expectations. Experience with technical writing and preparation of investigation, deviation, CAPA, and product impact documentation. Strong analytical and critical thinking skills with the ability to interpret manufacturing, equipment, and laboratory data. Excellent written and verbal communication skills with the ability to collaborate effectively across multiple functions. Preferred Qualifications: Direct experience with oral solid dose pharmaceutical manufacturing. Experience with blending, granulation, compression, coating, encapsulation, or related OSD processes. Experience with process validation, technical transfers, continuous improvement, automation, or digital manufacturing tools. Experience with electronic quality systems, manufacturing execution systems, laboratory information management systems, historian systems, or trending platforms. Operational Excellence experience or Green Belt or Black Belt certification. Experience supporting commercial manufacturing operations and inspection readiness. Benefits 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 paid sick and safe time hours of paid vacation time weeks of paid parental leave paid holidays annually - AS Applicable) #J-18808-Ljbffr