Astellas - QC Microbiologist
We are seeking a highly skilled and motivated Quality Control Microbiologist to join our team in Tralee, Ireland. At Astellas, we offer an inspiring place to work and the opportunity to make a meaningful difference for patients.
Our team is responsible for ensuring the quality of our products, and we are looking for a talented individual who can contribute to this mission.
About the Role
* Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in all tasks, including safety protocols.
* Oversee analytical technical transfers and qualification of Pharmacopeial methods for the laboratory.
* Manage environmental monitoring programs, product testing, trend reports, and related activities.
Responsibilities:
* Lead microbial testing training, troubleshoot instruments, and handle procedure/report writing.
* Author and update laboratory processes, manage incident reports, non-conformances, and CAPAs.
* Support cleanroom and aseptic process qualifications, participate in QC process improvement, and represent QC in cross-functional meetings.
Requirements:
* B.S. degree in Microbiology with relevant industry experience in a Pharmaceutical Quality Control lab or equivalent.
* Strong knowledge of Laboratory Information Management Systems (LIMS), SAP, Empower, and TrackWise.
* Extensive experience with instrumentation, including icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.
Additional Information:
This is a permanent, full-time position based in Tralee, Ireland. The successful candidate will be required to work 100% on-site/in the office.