
Micro Analyst
2 weeks ago
This is what you will do:
The QC Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water sampling, TOC, Bioburden, and Endotoxin.
You will be responsible for:
- Environmental and Facilities monitoring sampling and testing.
- Testing to support release and stability programs on site.
- Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
- Maintaining high standards of housekeeping and safety in the Laboratory.
- Completing project work and implementing initiatives to improve laboratory efficiency.
- Updating management on issues within the laboratory.
- Investigating out-of-specification/limit results using Structured Problem Solving, Root Cause Analysis, in collaboration with the Microbiology Laboratory Supervisor, QA, and other departments, and implementing corrective and preventative actions.
- Training laboratory personnel and contributing to training/re-training programs.
Qualifications:
- Minimum of 1 year experience in a cGMP Quality environment.
- Experience in testing sterile/non-sterile pharmaceutical/biopharmaceutical products.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance supporting cGMP operations.
- Degree in Microbiology or related science.
The duties are generally conducted in a lab environment. Employees must be able to lift/carry 15/30 pounds, work comfortably in controlled environments with biological, infectious, and hazardous materials, gown/degown PPE, use a computer, communicate via phone, video, and electronic messaging, and collaborate effectively. The role requires maintaining general availability during standard business hours.
Location: Alexion Dublin Manufacturing Facility
Reports To: Siobhan Devoy, QC Microbiology Senior Manager
Education: Degree in Microbiology or related science.
Date Posted: 19-Aug-2025
Closing Date: 18-Sep-2025
Our mission is to build an inclusive and equitable environment. We welcome applications from all qualified candidates and offer reasonable adjustments to support candidates with needs.
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