Description:

The Sr. Quality Management Systems Specialist provides coordination and reporting that includes data collection/generation, data analysis and data review and interpretation. In addition, prepares summary findings to support change controls, planned deviations, new product launch compliance, as well as quality assurance trends related to various Quality Management processes.

Essential Functions:

+ Reviews and approves (where applicable) respective data for the purpose of change, implementing, analyzing and reporting. The Specialist collects / generates data for the purpose of analyzing and reporting. Additionally, supports preliminary investigations and prepares a summary of the findings to support NOIs, CAPAs, Complaints and other Quality related activities and projects. Regularly audits the tasks completed for reporting purposes and identification of any possible outstanding actions for both Sterile and Non-Sterile Quality Operations

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