Manufacturing Quality Assurance Specialist - 3rd Shift
Company: Fagron Sterile Services
Location: Wichita
Posted on: May 15, 2022
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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
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