Microbiology Specialist

Core Skills:Strong cross-functional troubleshooting, communication, and negotiation skillsMaster’s or Ph.D. in Science/EngineeringExperience in cGMP investigations within pharmaceutical manufacturing (OSD preferred)Key ResponsibilitiesLead/develop cGMP investigations for OSD manufacturing deviations, nonconformances, and atypical eventsPerform root cause analysis using tools like 5-Why, Fishbone, and Fault TreeReview manufacturing, engineering, and QC data (MES, LIMS, SCADA, historian tools, batch records, etc.)Coordinate with QA, QC, Engineering, and Operations for event triage, containment, CAPA, and batch dispositionAuthor investigation reports, CAPAs, product impact assessments, and support audit readinessPreferred ExperienceOSD processes: blending, granulation, compression, coating, encapsulationeQMS, MES, LIMS, deviation/CAPA systems, trending tools, AI toolsOOS/OOT investigations, GDP documentation, data integrity, and pharmaceutical quality systemsKey TraitsStrong analytical/problem-solving skills, ability to manage multiple investigations, interpret manufacturing/lab data, and proactively drive resolutions in cross-functional environments.