**Batch Release Coordinator Role**
Located in the West of Ireland, this permanent position involves working with a thriving Contract Research Organization (CRO) as their next Quality Control Officer for Biologics.
This attractive role comes with an excellent salary and a comprehensive suite of benefits.
The successful candidate will oversee routine batch release testing in the Biosafety and Cell-Based Assay Department. This includes managing client correspondence, scheduling weekly calls, and ensuring subcontractors are managed effectively.
The key responsibilities include:
• Coordinating batch release testing to meet required timelines, including scheduling tests, reviewing data, and liaising with Quality Assurance teams.
• Developing and updating Good Manufacturing Practice (GMP) compliant Standard Operating Procedures (SOPs), protocols, and reports.
• Procuring and stocking consumables, standards, and reagents needed for testing.
• Receiving and processing test samples using Laboratory Information Management Systems (LIMS).
• Performing data calculations, basic statistics, and trending. Additional information can be provided upon request from clients.
• Assisting with internal, regulatory, and client visits/audits and responding to findings.
Minimum Requirements:
• A minimum of 2 years of relevant experience in scientific research within a GMP-regulated environment (EMEA/FDA) in the Pharmaceutical, Medical Device, or CRO Industry.
• Project management experience is desirable.
• Bachelor's or Master'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.
Please note that applicants must have a Stamp 4 or unrestricted full working rights in Ireland.