Astella's Culture of Doing Good
Our Mission and Values
We strive to make a meaningful difference in the lives of patients through our innovative approach to healthcare. Our culture is built on five core values: patient focus, ownership, results, openness, and integrity.
The Astella Way
Our ethos is centered around creating a patient-centric environment where every staff member feels valued and empowered to contribute. We foster an inclusive and respectful work atmosphere that promotes collaboration and ownership.
Patient Centricity
At Astella, we believe that every staff member has a role to play in creating a patient-centric culture. We prioritize understanding the patient experience and integrating it into our daily work practices.
The Opportunity:
The QC Biochemist will support operations by completing all required testing, including receipt, in-process, finished, and stability product testing. This role will also involve analytical method validation, technical transfer, and pharmacopeial method validation.
Responsibilities:
* Perform tasks in accordance with GLP and GMP to ensure safety compliance in the laboratory and facility.
* Train personnel on biochemical testing processes and document results in LIMS, ensuring peer review.
* Handle incident reports, non-conformances, CAPAs, OOS investigations, and lead QC process improvement projects.
* Author and update laboratory policies, procedures, and data trending, including Continuous Process Verification.
* Proficient in laboratory technologies including LIMS, SAP, Empower, and TrackWise.
* Extensive experience with instrumentation such as icIEF, Capillary Electrophoresis, Liquid Chromatography (ELS, TUV, FLR detectors), Polarimetry, and Moisture content analysis.
* Solid understanding and experience in completing Pharmacopeial testing.
Requirements:
* B.S. degree in Chemistry/Microbiology with relevant industry experience in a Quality Control lab or equivalent.
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.