QC Associate Senior – Sample Management
An opportunity has arisen for a QC specialist within a leading Dublin based biopharmaceutical manufacturing company.
This is not a lab based role with the successful candidate being a member of the Sample Management team with a supporting function for QC labs,
• Execute sample management activities across the site – sample distribution, LIMS logging
• Perform Stability Program related activities such as pulling stability samples, study initiations.
• Create/own and approve protocols, sample plans, SOPs, training manuals.
• Perform SAP, LIMS and CIMS functions/ transactions within the sample management remit
• Out of hours responder for sample management equipment (fridges /freezers / incubators)
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities.
• LIMS logging + data coordination of commercial and import batches.
• Management and maintenance of the site inventory of Reference Standards, Assay Controls, Training and Verification samples within an electronic management system
• Bachelor’s degree in a Science related field is required.
• 3-5 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
• Communication skills (verbal and written) at all levels
For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to [email protected]