Quality Control Microbiologist
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
The main functions of this position are microbiological analysis of raw materials, in-process and finished product, and utilities. Preparation of media for microbiological analysis including that for environmental monitoring and personnel monitoring. Utilisation of all equipment in accordance with good analytical techniques. Preparation of documentation and reports in an accurate and concise manner. Procedures to be carried out in accordance with GLP and GMP.
Key Responsibilities:
- To carry out all activities in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- To participate in internal auditing programs.
- To comply with safety procedures in laboratory i.e. the wearing of safety glasses, lab coats, correct disposal of waste etc.
- To participate in training sessions as requested by QC Management. Supervision of Trainees and of Students as required.
- To ensure that all tests are carried out accurately and efficiently in accordance with written procedures.
Media Preparation:
- Preparation and maintenance of stock levels if in-house prepared microbiological media and autoclaved equipment.
- Growth promotion analysis, pH testing and sterility checking of all lots of in-house prepared media and commercially prepared media.
Raw Material, In-process Samples and Finished Product Testing:
- Performance of specified microbial tests required for the various raw materials, in-process samples and finished products.
- These tests include but are not limited to: microbial limit tests, tests for specified organisms, endotoxin analysis and sterility testing.
- Reading and reporting of plates on completion of tests.
Water testing:
- Performance of the specified tests for potable, purified, water for injection and pure steam. These tests include but are not limited to total viable counts, test for coliform bacilli and endotoxin analysis.
- Reading and reporting of plates on completion of tests.
Microbial Identification:
- Performance of microbial identification of isolates in accordance with documented procedures.
Environmental & Personnel Monitoring:
- Preparation and testing of environmental and personnel monitoring.
- Result evaluation, generation of Alert/ Alarm Notices.
- Corrective action follow-up and close-out.
Instrumentation:
- To ensure that all instruments used are within calibration and to perform calibration when required.
Housekeeping:
- Autoclaving/ removal of microbial waste, compliance with departmental waste procedure.
- Ensuring that areas are cleaned in accordance with specified procedures.
- Ensure that when performing testing that all instruments are within their calibration period.
Documentation:
- Logbooks – complete and maintain in prompt and accurate manner.
- LIMS/ Data Sheets – report results in prompt and accurate manner and record all analytical data correctly.
- Out of specifications – report and investigate in a timely manner.
- Data such as environmental monitoring to be trended and reviewed on a regular basis.
Preferred Skills & Experience:
- Aseptic Technique Experience Culture Handling and/or experience in related industry is an advantage.
Education:
- Bachelor's degree in a Science or equivalent, preferably Microbiology related.
Additional Information:
- This position is based in Kerry Plant and will require on-site work.
- This position is a FTC until January 5th 2027.
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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