Job Title: Quality Assurance Specialist
We are seeking a highly organized and detail-oriented Quality Assurance Specialist to join our Biologics Division in Ireland. Reporting into the Biosafety and Cell Based Assay Department Manager, this is a permanent role with excellent benefits.
Key Responsibilities:
* Manage routine batch release testing in the Biosafety and Cell Based Assay Department, including client correspondence, weekly calls, subcontractor management, and sample release within required timelines.
* Develop and update GMP compliant SOPs, Protocols, and reports.
* Sources, purchases, and stocks consumables, standards, and reagents required for testing.
* Receive and process test samples in LIMS.
* Perform data calculations, basic statistics, and trending, providing additional information as required.
* Assist in internal, regulatory, and client visits/audits and respond to findings.
Requirements:
* Minimum 2 years of relevant experience in scientific research, preferably in a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, or CRO Industry.
* Experience in project management is essential.
* Bachelor's degree in a relevant science discipline (e.g., cell biology, molecular biology, biomedical science).
* Experience in cell-based assays/molecular techniques is desirable but not essential.
* Must have a valid work permit for Ireland.
Benefits:
This permanent role offers an excellent compensation package, opportunities for career growth and development, and a chance to work in a dynamic and supportive team.