Biologics Division Role
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We are seeking a Quality Assurance Specialist to join our expanding team in Ballina. The ideal candidate will have experience in project management, GMP compliance, and cell-based assays.
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The role involves:
* Project Management: Oversight of routine batch release testing, including client correspondence, weekly calls, subcontractor management, and ensuring samples are released within required timelines.
* GMP Compliance: Development and updating of SOPs, protocols, and reports to meet regulatory requirements.
* Sourcing and Procurement: Acquisition and stocking of consumables, standards, and reagents for testing.
* Sample Processing: Receipt and processing of test samples in LIMS.
* Data Analysis: Calculation, basic statistics, and trending of data, with additional information provided at clients' request.
* Audit Support: Assistance in internal, regulatory, and client visits/audits, with response to findings.
Requirements
* Experience: Minimum 2 years relevant experience in scientific research, preferably in a GMP-regulated environment (EMEA/FDA), within the pharmaceutical, medical device, or CRO industry.
* Project Management: Essential experience in project management.
* Education: BSc degree in a relevant science discipline (e.g., cell biology, molecular biology, biomedical science).
* Deseable Skills: Experience in cell-based assays/molecular techniques desirable but not essential.
* Working Rights: Applicants must have a stamp 4 or unrestricted full working rights for Ireland.
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This is a permanent role with excellent benefits and opportunities for growth and development.