QA Specialist/Senior QA Specialist, Manufacturing Quality
About the position 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 Apply tot his job