The Senior Quality Assurance Associate is responsible for administrative function, data reporting, document control, equipment control, auditing, regulatory compliance, stability, and manufacturing activities as needed.Start and stop work authoritySupports admininistration function by:Acting as the Deputy QAS/QAM in their absenceMonitoring quality systems deadlines and reports to management pending and overdue activitiesAssisting with the PO system for the QA group o maintaining Analytical Subcontractor complianceWriting, reviewing, and approving Events, CAPA, OOS/OOT and Change ControlManaging investigationsWriting, reviewing, and conducting Quality System, cGMP, and GLP trainingParticipating in data analysis and reportingServing as QA trainer, as neededSupporting sister sites(s) as requiredSupports all Quality Assurance I and II roles for:AuditingData reportingDocument controlEquipment controlManufacturing (as required)Stability (as required)Supports Auditing by:Performing Internal audits per Standard Operating ProcedureSupporting and hosting client and regulatory auditsConducting external auditsSupports Regulatory ComplianceSupports the Stability Program as needed by:Reviewing and approving Stability ProtocolsReviewing Stability Chamber Pull SchedulesReviewing and approving Stability Chamber mapping o monitoring and following up Stability Chamber excursions o other task as requiredSupports Manufacturing as needed by:Executing and reviewing batch recordsQuality assurance inspection and release of cGMP materials o reviewing, creating, and approving Batch RecordsReviewing, creating, and approving Certificates of ComplianceConducting cGMP vendor qualificationOther functions as assigned
