QC External Sample and Retain Coordinator
An exciting opportunity has arisen with a leading multinational pharmaceutical organization based in Carlow.
Responsibilities:
1. Act as the primary point of contact for quality control (QC) sample and retain management.
2. Manage QC external samples from receipt to shipment, ensuring timely and accurate processing.
3. Oversee the management of QC retain samples from receipt to disposal, adhering to Good Manufacturing Practices (cGMP).
4. Understand current cGMP regulations related to the QC laboratory and identify areas for process improvement.
5. Demonstrate proficiency in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
6. Showcase expertise in lab management software systems, such as LIMS.
7. Prepare and coordinate sample movement within the warehouse area.
8. Review electronic logs and/or LIMS to ensure accurate physical quantities of samples stored in freezers, refrigerators, and lean lifts.
9. Oversee processes related to sample handling, including freezer/refrigerator cleaning schedules.
10. Support sample management-related non-conformance investigations.
11. Participate in internal and regulatory audits.
12. Format, write, and deliver necessary documentation in line with global policies, procedures, and guidelines, as well as regulatory requirements.
13. SUPPORT continuous improvement by engaging with the laboratory team during investigations and corrective actions.
14. Ensure timely completion of all assigned documents to meet site metric requirements.
15. Work collaboratively to drive a safe and compliant culture in Carlow.
16. Attend QC daily tier meetings and communicate assigned tasks/projects effectively.
Experience and Education:
1. Bachelor's Degree or higher preferred, ideally in a science-related discipline.
2. At least 2 years' GMP experience, preferably in Quality within the Biological and/or Pharmaceutical industry.
3. Quality Control experience is highly desirable.