QC Specialist

Job Purpose:
The 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 within the company as required and support the Quality Assurance Team. LCMS Experience is required.

Key Responsibilities

• Drive 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.
  • Validation activities.
  • Retain management.
  • Data trending.
• Coordination of sample testing at 3^rd 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.
• Support Supplier qualification as requested.
• Support Audit preparation activities.
• 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.
• Any other responsibilities as required and assigned by the Quality Control Lead, Group Quality Manager or Director of Operations.           

Education and Experience:

• 3rd 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
• Appropriate computer skills
• Ability to work both independently and as part of a team
• Ability to work in a dynamic environment, with changing priorities.

Contact Fiona Fitzsimons for a confidential chat: [email protected]
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