Manufacturing Quality Assurance Specialist - 3rd Shift

Company: Fagron Sterile Services
Location: Wichita
Posted on: May 15, 2022

Job Description:

About the job Manufacturing Quality Assurance Specialist - 3rd ShiftThe MQA Specialist reports to the Manufacturing Quality Manager and works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique. Responsibilities :Ability to identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operationsResponsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.Provides review of production specific Deviations / Investigations, CAPAs, Change ControlsAssist in generating procedures related to Manufacturing QA functions / activitiesObserve and identify conformance to defined procedures and batch specific steps within the aseptic areasPeriodically review records to verify that quality standards for each drug product is metMaintain compliance with FDA 503B and cGMP guidelines / state and federal lawsPrepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunitiesResponsible to maintain all testing equipment in compliance, calibration and certification.Assists in developing policies and procedures related to QAPromptly communicates with Operations regarding complaints, product issues/variances.Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliationEnforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantlyAssist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.Conduct and report the findings of internal investigations of compliance issues.Set yourself apart Set Yourself Apart: Profile/Experiences High School Diploma with a BS/BA degree preferred.Minimum 2 years of pharmaceutical experience with experience in a quality/compliance function.Ability to multi-task, effectively communicate and make decisionsOversight of operations with a focus on Sterility AssuranceKnowledge of QMS and CAPA related tools or systems is preferred.Environmental, monitoring or audit experience is an assetExperience with inspections and inspection readiness activities preferred.What's on offer? We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Keywords: Fagron Sterile Services, Wichita , Manufacturing Quality Assurance Specialist - 3rd Shift, Other , Wichita, Kansas