At Astellas, we offer an inspiring workplace and the chance to make a positive impact on people's lives.
Astellas is a pharmaceutical company that combines expertise, science, and technology with an open and progressive culture that prioritizes doing good for others and contributing to a sustainable society.
We strive to deliver meaningful differences for patients by leveraging our global insights and expertise, as well as innovative partnerships.
Our Patient Centricity vision is to develop innovative health solutions through a deep understanding of the patient experience. This guiding principle drives our actions and encourages all staff members to contribute to creating a patient-centric culture in their everyday work.
Astellas' ethos is built around five core values: patient focus; ownership; results; openness; and integrity.
We provide a welcoming and respectful work environment that fosters collaboration and ownership.
We aim to bring together top talent from around the world, providing them with cutting-edge tools, resources, and a unique structure that promotes agility and entrepreneurial spirit.
The Opportunity:
The QC (Quality Control) Microbiologist role involves supporting operations by completing testing tasks such as environmental monitoring, product testing, report writing, procedure development, and training. The position also requires responsibility for analytical method validation tasks like technical transfers and pharmacopeial method validation.
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.
* 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.
* Position is based in Tralee – Ireland.
* This position requires you 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, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.#J-18808-Ljbffr