Quality Control Specialist

3 weeks ago

Shannon, Ireland Pbc Biomed Full time

Unit 4D,Western Business Park,Shannon,Co.ClareJob SummaryThe Quality Control Specialist will support the development and continuous improvement of Quality Management System at PBC BioMed in order to maintain ISO ***** & ISO **** certification.The Quality Control Specialist will primarily Perform all Quality Control Functions within PBC BioMed as required and support the Quality Assurance Team.Job CategoryQuality ControlJob DescriptionRole and ResponsibilitiesDrive the implementation of new processes and be involved in QC activities:Incoming Inspection.In-process testing.Raw material and final product release testing.Stability testing.Test method development.Validation activities.Retain management.Data trending.Coordination of sample testing at 3rd party Testing Laboratories.Responsible for performing analysis on Raw Material, intermediates, in process and final release analysis in accordance with GMP.Perform technical review of data generated in laboratory, validation protocols and reports.Management of QC Sample Retention.Any other responsibilities as required and assigned by the Quality Control Lead, Group Quality Manager or Operations Director from time to time.Perform the Quality Control verification of Customer Orders.Investigate out of specification or out of trend results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Lead, QA personnel and other relevant departments and to implement effective corrective and preventative actions.Provide assistance to the PBC BioMed team in the continuous improvement of the QMS to maintain ISO ***** and ISO ****.Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects.Support the implementation of Customer project activities at PBC BioMed.Review and Update Quality System Documentation as required.Support QA Activities such as NCR, CAPA, Change Controls.Support Supplier qualification as requested.Liaise with suppliers and service providers on quality control related activities.Perform all tasks in compliance with company policies and procedures.Support Key Projects.Provide direct support when required.Other duties as assignedQualifications and Education Requirements3rd level science, engineering or medical degree.Good planning and organizational skills.Good communication (oral and written)Hardworking and highly motivating individual, with a good attention to detail.Ability to work both independently and as part of a team.Ability to work in a dynamic environment, with changing priorities.Excellent interpersonal skills, communication skills (written and oral), customer focus (internal and external) and attention to detailNote: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.Apply for this RoleUpload your cover letter and resumé here.A maximum of 2 files can be uploaded and each file must be less than 10mb in size.Drop files here orDrop files here or Accepted file types: pdf, docx, doc, Max.file size: 10 MB, Max.files: 2.#J-*****-Ljbffr

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