Senior Microbiology Specialist
2 days ago
Grifols, S.A is a global healthcare company dedicated to improving the health and well-being of people around the world. As a leader in plasma-derived medicines and transfusion medicine, we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.
About the PositionThe Quality Control (QC) Microbiologist will play a critical role in ensuring the quality and safety of our products at Grifols Worldwide Operations (GWWO). Reporting to the QC Microbiology Manager, this position offers a chance to work in a state-of-the-art facility with excellent career development opportunities and a clear patient focus.
Main Responsibilities- Purified Water, Water for injection and Clean steam microbiological bioburden (TVC) and Endotoxin (LAL) analysis, as well as analytical testing as required.
- Carry out environmental monitoring, including Viable/non-viable particles monitoring in manufacturing facilities as needed.
- Conduct in-process and finished product microbiology analysis, including Total Viable Count (TVC), microbial ID, sterility, and Endotoxin testing as required.
- Ensure laboratory processes, equipment, and services are installed, qualified, and maintained appropriately.
- Participate in verification, validation, and technical transfer of microbiological and analytical testing procedures.
- Evaluate compliance with cGMP and company specifications.
- Investigate Out of Specification (OOS) and Out of Trend (OOT) results as necessary.
- Support CAPA initiatives and ensure adherence to QC documentation systems.
- Develop, improve, and implement QC procedures, processes, and systems.
- Collaborate on projects and continuous improvement initiatives within the Quality department and other functional areas.
- Participate in international project teams relating to QC and wider quality activities, potentially requiring travel.
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