Associate QC

Role overview

This position focuses on coordinating the qualification, calibration, and routine upkeep of laboratory systems within a cGMP quality control environment. The role also ensures that calibration and maintenance work performed by technicians is properly controlled, recorded, and monitored through the CMMS Maximo platform.

The ideal candidate will bring practical experience across the full lifecycle of laboratory equipment, including validation, maintenance, and regulatory documentation.

Core responsibilities

• Plan and carry out routine calibration, requalification, and maintenance activities for laboratory equipment, making sure all schedules are followed in CMMS Maximo.
• Review and archive QC calibration and maintenance records.
• Plan, execute, and document qualification work for new laboratory instruments in a cGMP-regulated setting.
• Prepare equipment validation protocols and the related summary reports.
• Complete periodic reviews of instrument validation throughout the validation lifecycle.
• Notify QC leadership if any equipment does not meet calibration or qualification standards, and lead impact reviews or investigations when needed.
• Arrange repairs and maintenance with external vendors or contractors while keeping downtime and disruption to lab operations to a minimum.
• Contribute to technical project teams as a subject matter specialist on instrument validation rules and procedures.
• Take ownership of change controls where required and monitor compliance with change control metrics.
• Support the addition of project components into CMMA Maximo.
• Serve as a key contributor to data integrity assessments for laboratory systems.
• Handle any other duties or projects assigned by the manager.

Experience and knowledge required

• A bachelor’s degree in a science-related discipline is mandatory.
• At least 3 years of experience in a cGMP laboratory setting.
• Hands-on exposure to analytical instrument validation and data integrity assessments.
• Strong understanding of biopharmaceutical testing methods, instruments, and analytical techniques.
• Good knowledge of current cGMP laboratory equipment validation standards and electronic record integrity requirements.
• Previous success managing equipment qualification or maintenance programs is considered an advantage.

Additional information

The role is based in Dublin, County Dublin, Ireland and is onsite. It is a contract opportunity. The work will be a mix of routine operational activities and project-based support, especially around the introduction and qualification of analytical equipment for QC use. The position calls for practical experience with laboratory equipment lifecycle management and validation.