Job Title: QC External Sample and Retain Coordinator
Location: Carlow
Summary of Role:
We are seeking an experienced Quality Control professional to join our team as a QC External Sample and Retain Coordinator. This is an exciting opportunity to work with an award-winning Pharmaceutical organization based in Carlow.
Key Responsibilities:
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 including 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 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
Requirements:
Bachelor's Degree or higher preferred; ideally in a science-related discipline
2+ years GMP experience, ideally in Quality within the Biological and/or pharmaceutical industry
Quality Control experience preferable