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Job Field: Government Jobs
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00401678Job348of363GMP Site Compliance AuditorOceanside, CaliforniaJob factsJob functionTechnical OperationsLocationUnited States - CaliforniaOceansideCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The Position* Independently lead/participate on GMP compliance audits andidentify GMP compliance gaps or risks.* Provide GMP compliance expertise to internal and externalcustomers. Perform tasks and work toachieve company goals and organizational objectives.* Follow company policiesand procedures.* Set personal performancegoals and provide input to departmental objectives.* Establish workpriorities to meet targets and timelines.* Manage competingpriorities and allocate, adjust, and optimize assigned department resources.* Serve as the Qualityrepresentative on cross-functional and multi-site teams.* Perform any other tasksas requested by Management to support Quality oversight activities* Manage department andcross-functional initiatives.* Apply advanced theory,technical principles, expert judgment, and cross-functional expertise toindependently address a broad range of complex problems.* Troubleshoot and directthe resolution of Quality issues by fostering effective interdepartmental andcross-functional partnerships.* Serve as a technicalsubject matter expert (SME) in support of department functions.* Develop and trainpersonnel and internal customers on relevant business processes.* Mentor junior personnelserving as a subject matter expert (SME) on Quality systems, processes andissues.* Collaborate and authordepartment policies and procedures.* Make decisions thatimpact the goals and objectives of the department.* Notify Management ofpotential quality or regulatory issues that may affect product quality orregulatory compliance.* Ability to communicateclearly and professionally both in writing and verbally* Expert knowledge ofGMPs/QSRs and other relevant compendia with ability to interpret and apply toGNE operations.* All employees with jobsthat require access to the Warehouse must be able to pass the TransportationSecurity Administration (TSA) Security Threat Assessment (STA).* Ensures the integrationof environmental health, safety, and security into the business processes, systems,and programs while reporting safety and environmental incidents includinginjuries, illnesses, and safety suggestions within one

KEY REQUIREMENTS:

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