Title: Quality Control Specialist
Location: Shannon, Co. Clare
Benefits: Good salary, bonus, pension and healthcare


Summary:
Quality Control Specialist will support the development and continuous improvement of Quality Management System in order to maintain ISO 13485 & ISO 9001 certification. The Quality Control Specialist will primarily Perform all Quality Control Functions as required and support the Quality Assurance Team.



Responsibilities:

Drive the implementation of new processes and be involved in QC activities:

• In-process testing.
• Raw material and final product release testing.
• Stability testing.
• Test method development/Validation.
• 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.
• Management of QC Sample Retention.
• Qualification & routine operation of LCMS and other analytical equipment.
• Ensure compliance with ASTM/ISO standard test methods.
• Perform technical review/verification of data generated in laboratory, validation protocols and reports.
• 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 team in the continuous improvement of the QMS to maintain ISO 13485 and ISO 9001.
• Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects.
• Support the implementation of Customer project activities.
• Review and Update Quality System Documentation as required.
• Support QA Activities such as NCR, CAPA, LIRs, Change Controls.