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 relevant departments, and implementing corrective and preventive actions to close investigations within the specified lead-time.
Training laboratory personnel and participating in the development, operation, and evaluation of 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.
Additional requirements:
The duties are generally conducted in a lab environment.
Employees must be able, with or without accommodation, to lift/carry 15/30 pounds, work comfortably in a controlled environment, gown/degown PPE, use a computer, communicate via phone, video, and electronic messaging, engage in problem solving, collaborate, and maintain availability during standard business hours.
Position: Microbiology Shift Analyst
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 accommodations for candidates who need them.
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