Quality Investigators

Job DescriptionThe Deviation Investigation Specialist will be responsible for managing deviation and investigation activities within a GMP-regulated environment. This role involves assessing deviation criticality, evaluating product impact, authoring investigations, and developing effective corrective and preventive actions. The specialist will collaborate with cross-functional teams to ensure compliant manufacturing operations, identify root causes using structured investigation methodologies, and support continuous quality improvement initiatives. The position also ensures the timely implementation and effectiveness of CAPAs while supporting quality system documentation and procedural updates.Key SkillsDeviation ManagementInvestigation ManagementProduct Impact AssessmentRoot Cause AnalysisCorrective and Preventive Actions (CAPA)GMP ComplianceCross-Functional CollaborationProcess Knowledge ApplicationQuality Systems DocumentationSOP Support and RevisionRequired QualificationsOpen deviations and assess the criticality of the deviation within required timeframesAssess impact to any products involved in deviations, ensuring product impact is assessed in alignment with batch release activitiesAuthor investigationsOwn investigations and develop corrective actionsUse process knowledge and root cause investigation tools to identify root causes of product and process deviationsEnsure robustness, completeness, accuracy, and defensibility of all critical and major investigationsAuthor and execute experiments or runs to support investigationsWork cross-functionally to assess and analyze deviations and investigations to determine impactWork cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordinglyGenerate and document effective corrective and preventative actionsEnsure all CAPAs are implemented through GMP systemsMonitor and ensure effectiveness checks of CAPAs are conductedCommunicate training or awareness events to reinforce quality behaviorsSupport SOP edits as requiredAdditional SkillsBatch Release SupportInvestigation DocumentationQuality Compliance MonitoringTraining CoordinationProcess Deviation AnalysisQuality Behavior ReinforcementExperimental Investigation Support