QA Specialist III/Senior QA Specialist, QA Operations (HIT)

Website Genentech

This position is part of Genentech’s’ Pharma Technical – individualized and cell therapy team based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology.

Responsible for lot disposition and release of commercial and clinical products according to the approved registration dossiers, ensuring internal standards are achieved and in compliance with local and international laws (e.g., Qualified Person/ Responsible Person). Create or revise quality documents. Provide Quality oversight for processes and procedures related to operations.

Support and lead cross-functional projects and Quality initiatives. Identify and participate in the resolution of Quality risks and issues by fostering effective interdepartmental and cross-functional relations.

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