Quality Control Investigation Deviation

Title: Sr. Staff MTO – Deviations, CAPA & Manufacturing InvestigationsEmployment Type: Contract (12+ Months)Status: Accepting CandidatesAbout the roleJoin a Manufacturing Technical Operations (MTO) team supporting Cell Therapy manufacturing operations. This role is responsible for owning and driving quality events, investigations, CAPAs, change controls, and operational compliance initiatives supporting GMP manufacturing activities.The ideal candidate will have strong experience managing manufacturing investigations, leading root cause analysis activities, driving CAPA execution, and supporting GMP manufacturing environments.Key ResponsibilitiesTriage manufacturing issues in real-time on the manufacturing floorLead investigations supporting:Manufacturing OperationsQuality ControlMaterial OperationsFacilities OperationsOwn and manage:DeviationsCAPAsChange ControlsEffectiveness ChecksLead root cause analysis activities using structured investigation methodologiesCollaborate with SMEs to:Assess impactDetermine containment actionsDevelop corrective actionsDrive CAPA and Change Control records from initiation through closureManage records within electronic Quality Management Systems (eQMS)Ensure compliance with GMP requirements and internal quality standardsPromote operational compliance best practices and support continuous improvement initiativesTrack and communicate quality metrics and operational compliance performanceSupport manufacturing operations and clinical production timelinesQualificationsBachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, Biology, or related discipline6+ years of pharmaceutical, biotech, biologics, or cell therapy manufacturing experienceStrong experience owning:DeviationsCAPAsChange ControlsStrong experience performing manufacturing investigations in GMP environmentsExperience conducting root cause analysis and implementing corrective actionsStrong technical writing and documentation experienceExperience working within electronic Quality Management Systems (eQMS)Strong communication and cross-functional leadership skillsAbility to independently manage multiple investigations and compliance activitiesPreferred QualificationsCell & Gene Therapy (CGT) experienceBiologics manufacturing experienceGrade B cleanroom gowning experienceExperience supporting manufacturing floor investigations in real-timeExperience supporting regulatory inspections and audit readiness activitiesExperience using:VeevaTrackWiseMasterControlSimilar eQMS platformsCompensationEstimated hourly range: $50–$56/hr (W-2)Final rate will be based on skills, experience, and interview results.#J-18808-Ljbffr

Title: Sr. Staff MTO – Deviations, CAPA & Manufacturing InvestigationsEmployment Type: Contract (12+ Months)Status: Accepting CandidatesAbout the roleJoin a Manufacturing Technical Operations (MTO) team supporting Cell Therapy manufacturing operations. This role is responsible for owning and driving quality events, investigations, CAPAs, change controls, and operational compliance initiatives supporting GMP manufacturing activities.The ideal candidate will have strong experience managing manufacturing investigations, leading root cause analysis activities, driving CAPA execution, and supporting GMP manufacturing environments.Key ResponsibilitiesTriage manufacturing issues in real-time on the manufacturing floorLead investigations supporting:Manufacturing OperationsQuality ControlMaterial OperationsFacilities OperationsOwn and manage:DeviationsCAPAsChange ControlsEffectiveness ChecksLead root cause analysis activities using structured investigation methodologiesCollaborate with SMEs to:Assess impactDetermine containment actionsDevelop corrective actionsDrive CAPA and Change Control records from initiation through closureManage records within electronic Quality Management Systems (eQMS)Ensure compliance with GMP requirements and internal quality standardsPromote operational compliance best practices and support continuous improvement initiativesTrack and communicate quality metrics and operational compliance performanceSupport manufacturing operations and clinical production timelinesQualificationsBachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, Biology, or related discipline6+ years of pharmaceutical, biotech, biologics, or cell therapy manufacturing experienceStrong experience owning:DeviationsCAPAsChange ControlsStrong experience performing manufacturing investigations in GMP environmentsExperience conducting root cause analysis and implementing corrective actionsStrong technical writing and documentation experienceExperience working within electronic Quality Management Systems (eQMS)Strong communication and cross-functional leadership skillsAbility to independently manage multiple investigations and compliance activitiesPreferred QualificationsCell & Gene Therapy (CGT) experienceBiologics manufacturing experienceGrade B cleanroom gowning experienceExperience supporting manufacturing floor investigations in real-timeExperience supporting regulatory inspections and audit readiness activitiesExperience using:VeevaTrackWiseMasterControlSimilar eQMS platformsCompensationEstimated hourly range: $50–$56/hr (W-2)Final rate will be based on skills, experience, and interview results.#J-18808-Ljbffr

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