Job Description

The Quality Assurance Engineer II will join the Quality organization by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The will support a new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. 
Responsibilities of the position include supporting quality systems and oversight to ensure the product process validation, cleaning validation, Quality Risk Management and quality laboratory systems meet cGMP and company compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications. 
Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight to ensure FDA requirements are met. 

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