At Astellas, We Make a Difference in the Lives of Patients
We are a pharmaceutical company driven by our passion to deliver meaningful differences for patients. Our expertise, science, and technology make us a leader in the industry, but it's our open and progressive culture that truly sets us apart.
Our Culture: A Guiding Principle for Action
Our global vision is centered around Patient Centricity, which means we prioritize understanding the patient experience and developing innovative health solutions. This guiding principle drives everything we do and ensures that all staff members have a role to play in creating a patient-centric culture.
The Astellas Way: Five Core Values
Our ethos is built on five core values: patient focus, ownership, results, openness, and integrity. These values underpin everything we do and ensure that we maintain a commitment to quality and excellence in all our work.
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The Opportunity: QC Microbiologist
As a QC (Quality Control) Microbiologist, you will play a critical role in supporting operations through completion of all testing required, including environmental monitoring, product testing, report writing, procedure development, and training. You will also be responsible for tasks associated with analytical method validation, technical transfer, and pharmacopeial method validation.
Key Responsibilities:
* 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.
* 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.
* Proficient in completing Pharmacopeial testing with a solid understanding of relevant standards.
Additional Information:
This is a permanent, full-time position based in Tralee – Ireland. The successful candidate will be required to be 100% on-site/in the office. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.