Stability Coordinator
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About The Position
The GQSS Stability Coordinator plays a pivotal role in managing all Stability programs within the Global Quality Shared Services (GQSS) framework. This position is responsible for overseeing the entire Stability process, which begins with the preparation of the annual master plan for the products involved. The coordinator is tasked with coordinating sampling and shipping with various sites in a timely manner, ensuring that all protocols are accurate in collaboration with Contract Testing Labs, and supervising the entry of results into the company's systems. Furthermore, the GQSS Stability Coordinator is instrumental in assessing data and generating necessary trend reports that scientifically demonstrate the stability performance of products. In addition to these responsibilities, the GQSS Stability Coordinator acts as a Subject Matter Expert (SME) and collaborates with various roles both within and outside of GQSS that are involved in the Stability program flow. This includes working closely with personnel overseeing Contract Testing Labs, TCS Stability Analysts responsible for GLIMS data entry, site planners, and the Global Stability team. The position reports to the Global Quality Shared Services Director or the Associate Director of Contract Testing Labs for general guidance and instruction, while also having the autonomy to function independently. Key activities include the creation of an annual Site Master List for all studies managed through GQSS, based on global stability protocols, and the maintenance of SDS requirements as per the master plan. The coordinator is responsible for coordinating the end-to-end stability process, which involves aligning study start dates with sites and labs, reviewing draft revisions of General Stability Protocols, and approving Batch Specific Protocols. The role also requires the completion of Impact Assessments and managing stability-related change controls, as well as acting as a second person reviewer for annual summaries and trending reports. The GQSS Stability Coordinator is expected to perform statistical trend analysis, support stability-related lab investigations, and participate in site and off-site project meetings.
