101113 QA Specialist III
Genentech, Inc. - South San Francisco, CA

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Level: E2/E3 Follow company policies and procedures and be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Lead product complaint investigations with moderate guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems. Solve a wide range of difficult issues that impact multiple functions related to product complaint management, following cGMP regulations and Genentech standards.

Ensure appropriate application and integration of cGMPs into the product complaint management system. Provide input to the development of personal performance goals and departmental objectives. Collaborate with Management to establish and meet targets and timelines. Perform assigned tasks and work to achieve company goals and department objectives.

Manage competing priorities. Serve as the Quality representative on cross-functional and multi-site teams. Identify, design, and implement process and system improvements. Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

Train personnel and internal customers on relevant business processes. Inform management of critical product complaints and provide timely impact assessments of potentially affected products, materials or processes. Review and approve product complaint investigation reports and supporting documentation. Lead collaboration with departments to establish appropriate, efficient, and timely investigation strategies.

Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes. Perform any other tasks as requested by Management to support Quality oversight activities.Who You AreB.A. or B.S. degree (preferably in Life Science) and at least eight years’ experience in relevant field(s), e.g., Pharmaceutical/biopharmaceutical experience, quality management, pharmacy, nursingSound knowledge of cGMPs or equivalent regulationsSound knowledge of product complaint handling associated with [Small Molecules/Biologics] products.Ability to interpret and relate Quality standards for implementation and reviewAbility to communicate clearly and professionally both in writing and verballyAbility to make sound decisions about scheduling and managing proritiesFlexibility in problem solving, providing direction, and work hours to meet business needsDemonstrated ability to understand and organize technical data for communication and analysis

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Genentech, Inc. (Genentech) is a biotechnology company that discovers, develops, manufactures and commercializes pharmaceutical products to...