Manufacturing Quality Assurance Specialist

This job was posted by https://www.kansasworks.com : For moreinformation, please see: https://www.kansasworks.com/jobs/13550142The MQA Specialist reports to the Manufacturing Quality Manager andworks closely with Operations personnel and Environmental MonitoringTechnicians to complete on-the-floor audits and training of behavior andtechnique.**Key Responsibilities** Ability to identify and report on QA events related to maintenanceof aseptic conditions within clean rooms with a focus on SterilityAssurance during manufacturing operations Responsible for timely and accurate process review of batch recordsand QA checks within the manufacturing process. Provides review of production specific Deviations / Investigations,CAPAs, Change Controls Assist in generating procedures related to Manufacturing QAfunctions / activities Observe and identify conformance to defined procedures and batchspecific steps within the aseptic areas Periodically review records to verify that quality standards foreach drug product is met Maintain compliance with FDA 503B and cGMP guidelines / state andfederal laws Prepares weekly/monthly reports, prepares metrics and trends data toidentify and prioritize continuous improvement opportunities Responsible for maintaining all testing equipment in compliance,calibration, and certification. Assists in developing policies and procedures related to QA Promptly communicates with Operations regarding complaints, productissues/variances. Assists in maintaining compliant controlled substance documentationspecifically associated with sample handling and reconciliation Enforce compliance with QA processes, Equipment Qualification, andComputer System Validation principles. Support all regulatory andcustomer quality audits. Gather, organize & analyze data to develop solutions & alternativemethods of proceeding compliantly Assist CAPA teams, and other project teams, in the development ofaction plans and implementation schedules, and the verification ofcompleted actions. Conduct periodic internal reviews or audits to ensure thatcompliance procedures are followed. Conduct and report the findings of internal investigations ofcompliance issues.