End-to-end responsibility of RotaTeq vaccine operations. Responsibility for drug substance, drug product, and packaging operations.

QA lead responsible for shop floor inspections, data review and approval, investigation review and approval, and technical document review and approval in support of Laboratory Operations Microbiology and Sterility Organization.Site Data Integrity LeadData Integrity Lead for Vaccines Line of BusinessResponsible for Quality Operations Financial Portfolio

Automation ComplianceData IntegrityNetwork System Owner for Deviation ManagementProfit PlanCapacity Modeling Facilities Management - Capital Projects in QC Laboratories

Business System Owner for Investigation Systems (TrackWise and SAP-CAPA)Business System Owner for LabWare LIMSBusiness System Owner for Data HistorianResponsible for CAPA Effectiveness ProgramManage the Annual Product Review for the Biotech productsOversee the site administration for GXPharma and MESAccountable and responsible for leading a technical team whose responsible for the implementation of the LACES LIMS master dataQuality Assurance Change Control Committee representative for LACES LIMSLiaison with Regulatory Boards of Health with respect to Investigations, Annual Product Review, and LACES LIMSRepresentative on the site’s Compliance TeamResponsible for the implementation of Level I and Level II documents as they relate to LACES LIMS, Data Historian, Annual Product Review and Investigations.

Business System Owner for TrackWiseResponsible for implementation and compliance of the investigations process (procedures) across the sitePerform Corrective Action/Preventive Action VerificationsLiaison with Regulatory Boards of Health with respect to InvestigationsRepresentative on the site’s Compliance Team

Design, develop and evaluate plans for projects/studies/investigations/reviews.System Champion for Investigation ProcessManage the implementation of Level I and Level II documents by the effective dateProvide Inspection Readiness Support

Manage departmental commitments. Monitor commitments issued to the department to ensure that they are clearly written/concise and if applicable, directly address the root cause of the investigation.Manages the change control process within the PPU. Assures that change controls are completed in compliance with SOPs and cGMPs.Perform monthly housekeeping audits of the manufacturing/mechanical areas to ensure compliance with GMPs. Recommend remediation and report findings of these audits to area owners and department managers in a timely mannerManage the customer complaints assigned to the PPU.Act as compliance meeting facilitator on a monthly/quarterly basis as needed to discuss compliance issues with Departmental personnel.

Perform Manufacturing investigation to identify root cause, suggest corrective actions, complete technical writing, and oversee closure Participated in cross-function team meetings to resolve open issues related to manufacturing discrepanciesFacilitated meetings concerning the initiation and closure of commitmentsEnsured timely completion of manufacturing discrepancy and external/internal audit commitments

Performed Personnel Gown CertificationsPerformed Environmental MonitoringParticipated in Environmental Room Qualifications