QC Chemist III at Gilead in Cork

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The QC Chemist III is an experienced individual contributor responsible for the planning, execution, review, and coordination of Quality Control activities supporting incoming materials and packaging components at Gilead Sciences Ireland UC (GSIUC), Cork. The role requires sound knowledge of Quality Control systems, analytical methods, specifications, and procedures and includes complex or non-routine assignments requiring scientific judgment, problem solving, and review of relevant data and factors. Key responsibilities include: Comply with applicable Quality Management System, SOP, cGMP, data integrity, regulatory, and Environmental, Health and Safety requirements. Perform and coordinate the receipt, sampling, testing, review, and documentation of incoming materials and primary and secondary packaging components in accordance with approved specifications, procedures, sampling plans, and pharmacopoeial requirements. Review analytical data and test results for accuracy, completeness, data integrity, and compliance, and maintain records in applicable systems, including GLIMS/LIMS, LES, GVault/QDMS, and SAP. Coordinate testing and review activities to support manufacturing priorities, material need-by dates, packaging plans, and the timely disposition and release of materials and components. Lead or coordinate investigations into OOS, OOT, atypical results, deviations, data discrepancies, method or equipment issues, and material or component nonconformances, including root-cause analysis, impact assessment, and CAPA support. Prepare, review, and revise controlled technical documentation, including SOPs, methods, specifications, monographs, datasheets, protocols, investigation reports, qualification reports, and laboratory records. Support the introduction of new materials, packaging components, suppliers, grades, and part numbers through change control, technical assessment, method verification, qualification testing, specification updates, and system configuration. Coordinate contracted testing activities with approved external laboratories, including sample shipment, documentation, result review, and compliance with quality agreements. Provide technical guidance, training, and day-to-day support to colleagues, acting as a technical resource for assigned materials, components, methods, instruments, or laboratory processes. Maintain inspection readiness and support audits through accurate, complete, contemporaneous, and readily retrievable records. Drive continuous improvement and participate in cross-functional projects relating to materials, packaging components, analytical methods, laboratory systems, compliance, and operational excellence. Promptly escalate safety, quality, compliance, testing, and delivery risks, and collaborate effectively with relevant internal and external stakeholde