QC Analyst

2 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Cpl in partnership are looking for a Quality Control Analyst - Sample Management to join their team for a contingent fixed term contract at their modern facility in Grange Castle, Dublin.

Responsibilities:

  • Routinely handle manufacturing test samples and distribute them to the relevant analytical laboratories.
  • Maintain procedures to ensure the chain of custody for QC samples.
  • Manage incoming shipments from external sites, verify sample inventory, process samples, and distribute to QC test labs.
  • Coordinate shipment of Drug Product and regulatory samples to BOH sites.
  • Oversee stability sample processes including study enrollment, sample shipment, and study disposal.
  • Maintain reserve program, including inspection of samples and equipment.
  • Manage reference material inventory.
  • Review and approve QCSM standard operating procedures, sampling and analysis plans, and stability protocols.
  • Facilitate laboratory investigations and support product investigations.
  • Prepare and review QC APQR and periodic review reports.
  • Engage proactively with customers and stakeholders to deliver samples within specified timelines.
  • Represent QCSM at team meetings and drive associated deliverables.
  • Contribute to complex projects, manage time effectively, and develop plans for work activities.
  • Participate in new initiatives for process improvement and efficiency.
  • Ensure compliance with cGMP, corporate standards, site policies, and regulatory requirements.
  • Assist in technical writing assignments and training programs.

Education/Experience:

To qualify for this role:

  • Hold a Third level Qualification in Science, Engineering, or related field.
  • Have a minimum of 4 years' experience in Quality Control or Quality Assurance.
  • Experience in Sample and Stability Management, Product Inspections, and lab systems is advantageous.
  • Possess excellent communication and interpersonal skills.
  • Demonstrate collaboration and effective team work, along with the ability to work independently.

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