特殊技能:Must have at least 1 year of prior work experience in each of the following 1.Working with quality system requirements including U.S. FDA GMP, EMA, and ICH guidelines. 2.Applying quality engineering principles including, Design of Experiment, structured problem solving, and root cause investigations. 3.Participating in regulatory inspections to ensure compliance. 4.Performing and reviewing pharmaceutical investigations including deviations, nonconformances, and supplier investigations using electronic systems such as TrackWise. 5.Conducting root cause analyses and identifying Corrective and Preventive Actions using Quality System management processes to prevent recurrences of quality issues in the manufacturing area. 6.Reviewing change controls and supplier batch records to ensure compliance with internal and regulatory requirements. 7.Driving continuous improvement using quality tools such as lean, six sigma, and risk management. 8.Executing statistical data analysis using Minitab or JMP statistical analysis software. 9.Managing and providing oversight of quality system records such as deviations, CAPA, change controls, supplier investigation, and corrective actions request using TrackWise.br br Position requires 25 travel. Position allows telecommuting, applicant may reside anywhere in U.S. and report to South San Francisco, CA. Any incurred business travel will be fully reimbursed.br br Experience must be progressively responsible and postbaccalaureate.