QA Specialist

This job was posted by https://www.kansasworks.com : For moreinformation, please see: https://www.kansasworks.com/jobs/13549088The Quality Assurance Specialist is an intermediate level professionalposition responsible for quality assurance activities associated withcGMP manufacturing, documentation, and product disposition. Ensures thatproper controls are followed and maintained during the manufacturing,processing, packaging, and warehousing of compounded products.**Key Responsibilities** Execute and develop proficiency in all Level 1, Level 2, and Level 3Quality Assurance Tasks Level 1: Manufacturing / Packaging Line Clearances Product Label Review and Approval Product Label Reconciliation EMS Data Review Logbook Review and reconciliation Level 2: Batch Record Issuance Batch Record Review and Approval Incoming Material Review and Approval Form and Logbook Issuance Review and Approval of Testing Data Review and Approval of Event Reports and Associated CorrectiveActions Level 3: Disposition and Release of Incoming Materials Disposition and Release of Finished Product Document Control Activities Review and Approval of Change Controls and controlled documentchanges Special Projects as assigned Review and Approval of Moderate Risk Deviations Support execution of product Batch Records and associatedmanufacturing and Quality related systems for the compoundingprocesses. Ensure day-to-day compliance to all requirements established forcompounded product and the systems supporting compounding. Assist with problem identification and resolution efforts forquality related issues associated with the compounding operations. Assist with internal, corporate, 3rd party and federal/stateinspections and audits. Provide contributing information on measures of local quality systemeffectiveness such as right the first time, documentation errors andothers as assigned. Ensure cGMP documentation associated with work activities meetsALCOA standards. Maintain assigned training standard operating procedures. Perform other related duties as assigned.