Senior Quality Assurance Specialist

3 weeks ago


Lexington, Kentucky, United States Genezen Full time
Job Summary

The Senior Quality Assurance Specialist - Laboratory Operations supports the day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, and data integrity in support of biologics manufacturing production with a focus on Quality Control activities.

Additional responsibilities include providing supportive services to the Facilities Management (FM) and Manufacturing (MFG) groups including QA review of controlled documents related to product/utilities testing, and data review.



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