Gilead Sciences - San Dimas, CA
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Gilead Sciences is currently seeking a Quality Minded Manufacturing specialist to join its newly formed Investigative team. This position will focus on a wide variety of functions associated with investigating deviations to facilitate effective root causes analysis and identification of corrective and preventative actions for continuous improvement of manufacturing operations. Will work with the QA organization to support and establish standards and levels of competence for documenting quality investigations related to manufacturing. Promotes use of established root cause analysis techniques as part of a thorough investigation process and provides technical guidance and support to investigation task owners.
Plans, executes and tracks a variety of manufacturing projects in the production of commercial products, clinical active pharmaceutical ingredients (APIs) and intermediate batches both internally and in coordination with contract manufacturers. Contributes to the development of department strategies for obtaining and outsourcing raw materials, intermediates and APIs. Coordinates cross-functional efforts to resolve manufacturing issues in projects. May participate in audits to include internal, vendors, contract manufacturers, or APIs. Coordinates technical transfer efforts internally and with contract manufacturers or raw material suppliers. May review and approve batch record and processing documentation, including planned or unplanned deviations. Implements systems for tracking project progress.