Job Summary:
This is a day-to-day role based on site, Monday to Friday. The successful candidate will support the Quality Control Department in managing external sample shipments and sample management.
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
* 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
* Perform or support sample management related non-conformance investigations
* Support 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
Qualifications:
* Third Level qualification preferred, ideally in a related field
* Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting
Skills:
* LIMS
* QC External Sample Management
* eLogs