22735-QC External Sample and Retain Coordinator-Carlow Contractor

Purpose 

Responsible for supporting the Quality Control Department in the management of external sample shipments and retaining sample management. Support various administrative duties associated with sample management. Ensuring that objectives are effectively achieved to, and consistent with Company requirements to ensure compliance, safety, and reliable supply to our customers. This is a Day role based on site (Mon-Fri)

Responsibilities 

• Will act as point of contact for QC sample and retain management.
• Responsible for QC External sample management from receipt to shipment.
• Responsible for QC retain sample management from receipt to disposal.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC Laboratory and ability to identify gaps in processes or systems.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Proficient with Lab management software system (LIMS).
• Prepare documents and coordinate Sample movement within the Warehouse area.
• Review eLogs and/ or LIMs to align physical quantities of samples in freezers/refrigerators/lean lifts and sample cages.
• Take ownership of processes related to sample handling e.g. oversight of freezers/refrigerator clean schedule.
• Perform or support sample management related non-conformance investigations.
• Supports Internal and Regulatory Audits.
• Format, write and deliver necessary documentation in line with Merck Global Policies, Procedures and Guidelines, regulatory requirements.
• Support continuous improvement by active participation and engagement with laboratory team during investigations and subsequent corrective actions.
• Ensure timely completion of all assigned documents to meet site metric requirements.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• Participate in QC daily tier meetings and ensure effective communication of assigned tasks/projects.
• May be required to perform other duties as assigned.

Qualifications

• Third Level qualification preferred, ideally in a related
• Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting.