QC External Sample and Retain Coordinator
Orion Group View all jobs
- Carlow
- Contract
- Full-time
- 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 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.
- Proficiency in Microsoft word, Office, excel and job-related computer applications required i.e. LIMS
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Understanding of Lean Six Sigma Methodology preferred
- Third Level qualification preferred, ideally in a related discipline.
- Experience and/or a particular skill set in their area of expertise that adds value to the Business, preferably GMP setting.