QA Specialist/Senior QA Specialist, Manufacturing reputed company

About the position Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of reputed company's reputed company portfolio & pipeline products. The Operations organization at HTO is divided into 2 production streams, which combine to produce millions of reputed company of life-saving medicine every year to patients around the world. In this exciting role, you will reputed company reputed company manufacturing reputed company reputed company 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 reputed company as a mentor and reputed company for the organization. Responsibilities • reputed company as key reputed company contact to manufacturing for discrepancy management, line support and batch review for reputed company and launch products. • reputed company reputed company reputed company reputed company 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 reputed company subject matter expert. • reputed company new approaches to reputed company problems. • reputed company coordination and issue reputed company across HTO Manufacturing Operations, support reputed company and/or reputed company. • Set the strategic direction and reputed company of one or multiple programs reputed company HTO reputed company in the areas of process development, process improvement, reputed company and compliance. • Own the deliverables reputed company the established programs and reputed company teams in their execution in line with the site reputed company. • Manage key operational support activities reputed company to product transfers and new equipment/process start-up. Requirements • Bachelor's degree (preferably reputed company 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-reputed company issues. • Deep understanding of safety, reputed company systems, and reputed company 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 reputed company assurance principles, reputed company systems, microbiology, and sterility assurance. • Effective communication skills for reputed company and sensitive information. • Ability to gown into production reputed company. reputed company-to-haves • Master's degree (preferably reputed company the Life Sciences or Engineering). • Experience in nPFS (reputed company reputed company-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 Apply To this Job