- Perform audits for monitoring records, and ensuring overall compliance with company quality systems and Assist in maintaining the established quality system, ensuring compliance with any requirements affecting the center
- Perform comprehensive QA reviews of external sample and product shipment releases, as well as associated shipping records and Review training records to ensure alignment with SOPs, training manuals, and regulatory requirements
- Regularly review Standard Operating Procedures (SOPs) to ensure the incorporation of the most recently approved procedures and forms into center procedure manuals and Ensure compliance with federal, state, local, and company-specific regulations pertaining to product quality, employee and donor safety, and the proper execution of day-to-day activities
- Review and validate Quality Control checks on equipment, reagents, and records to confirm they have been performed as required and fall within acceptable ranges
- Assist in, conduct, and evaluate center training and orientation programs to ensure the ongoing development and compliance of center staff
A
Aerosol Containment Container
Regulatory Intern
September 2022 - December 2023
Clinical informatics Specialist Oak Street Health
July 2023 - October 2023
A
Aplomb Technologies
Validation Analyst
January 2023 - July 2023
Z
Zifo RnD Solutions
Validation Analyst
January 2022 - April 2022
See 2 More
Skills
Advanced Cardiovascular Life Support (ACLS)AerosolsAuditing SkillsBilling ProcessesBiochemistryBiomedical EngineeringBiosafetyCarrying out AssessmentsChange ControlChemical ReagentsChemistryClinical PracticesClinical ResearchClinical WorksCommunication SkillsCoordination SkillsCorrective and Preventive ActionCPT CodingDelivery of ProjectsDental ImplantDental SurgeryDesign SpecificationsDrug DiscoveryElectronic Data CaptureElectronic Medical RecordsEngineering Validation TestsExecution of ExperimentsExpeditingFunctional DesignGood Clinical PracticesGood Manufacturing PracticesHealth CareHealth InformaticsHealth Insurance Portability and Accountability Act ComplianceHealth PhysicsHealth SciencesIBM Rational ClearCaseImplantable Cardioverter-DefibrillatorInformation TechnologyInstructional ManualsIq/oq/pqISO 9000Knowledge of EngineeringLaboratory Information Management SystemsLeadershipLegal KnowledgeManufacturingManufacturing LaboratoryMass ProductionMedical ManagementMedical MaterialsMedical RecordsMicrosoft ExcelMicrosoft OfficeMicrosoft OutlookMicrosoft PowerPointMicrosoft ProjectMicrosoft WordOsteoarthritisPerformance TestingPhysiologyProduct DesignProject ManagementQuality ControlQuality ManagementRegulatory AffairsRegulatory ComplianceRegulatory RequirementsRequirements TraceabilityResearch SkillsRheumatologyRisk AnalysisRisk ManagementSafety PrinciplesSchedulingSoftware EngineeringSoftware Product ManagementSoftware Requirements AnalysisStandard Operating ProceduresStrategic ManagementSurgical ProceduresSystematized Nomenclature of MedicineSystem LifecycleSystems Development Life CycleTest ScriptsTitle 21 of the Code of Federal RegulationsTraceability Matrix