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NEW ROLE: Our client, an early-stage contract research organization, is seeking a Senior In Vitro Bioassay Analyst to join their expanding team in Ballina. The role reports to the Biosafety & Cell Based Assay Supervisor.
This is a permanent position with excellent benefits. Reach out to Deirdre for more information.
Role Responsibilities:
1. Maintenance and propagation of antibiotic-free cell cultures.
2. Microscopic evaluation of mammalian cells (e.g., cell morphology, count, and viability).
3. Provide technical training to team members as required.
4. Receipt and processing of test samples in LIMS.
5. Update standard operating procedures.
6. Assist in laboratory investigations as needed.
7. Report progress and findings to management.
8. Assist during internal, regulatory, and client visits/audits and respond to findings.
9. Ensure compliance with all regulatory guidelines.
10. Collaborate with the Quality Department to generate departmental quality documents, including audit responses, facility replies, and deviation reports.
11. Generate GMP-compliant SOPs, protocols, and reports.
12. Conduct risk assessments for laboratory and test items as required.
13. Maintain laboratory data integrity and compliance.
Minimum Requirements:
* BSc/MSc in a relevant science discipline (e.g., chemistry, biochemistry, pharmacy, biotechnology).
* Minimum of 3 years relevant experience in a laboratory, preferably within a GMP-regulated environment (EMEA/FDA) in the Pharmaceutical, Medical Device, CRO, CMO, or CDMO industry.
* Applicants must have a Stamp 4 or unrestricted full working rights for Ireland.
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