QA Specialist/Senior QA Specialist, Manufacturing Quality

About the position Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 production streams, which combine to produce millions of units of life-saving medicine every year to patients around the world. In this exciting role, you will provide direct manufacturing quality oversight at HTO. As part of a dynamic and inclusive team, you will partner with manufacturing and other stakeholders at the site and in the network to supply patients. You will apply knowledge of aseptic drug product manufacturing processes, of health authority expectations and industry standards. You will act as a mentor and coach for the organization. Responsibilities • Act as key quality contact to manufacturing for discrepancy management, line support and batch review for commercial and launch products. • Provide quality oversight related to operational activities, procedures and processes. • Ensure that investigations are accurate, include appropriate corrective actions, and follow regulations, industry guidelines and company standards. • Support internal cGMP audits and Health Authority inspections as a technical resource and quality subject matter expert. • Develop new approaches to complex problems. • Lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects. • Set the strategic direction and framework of one or multiple programs within HTO Quality in the areas of process development, process improvement, quality and compliance. • Own the deliverables within the established programs and lead teams in their execution in line with the site strategy. • Manage key operational support activities related to product transfers and new equipment/process start-up. Requirements • Bachelor's degree (preferably within the Life Sciences or Engineering). • At least 5 years of experience in the pharmaceutical industry for QA Specialist; at least 8 years for Senior QA Specialist. • Strong problem-solving skills and ability to troubleshoot and resolve process-related issues. • Deep understanding of safety, quality systems, and quality assurance concepts including cGMPs in aseptic processing and production. • Solid understanding of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing. • Knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance. • Effective communication skills for complex and sensitive information. • Ability to gown into production space. Nice-to-haves • Master's degree (preferably within the Life Sciences or Engineering). • Experience in nPFS (nested pre-filled syringe) filling. • Experience in medical devices. Benefits • Discretionary annual bonus based on individual and Company performance. • Relocation benefits. Apply tot his job