Quality Assurance Engineer – Facilities & EquipmentGravity IT Resources

The Quality Engineer will join the Quality organization at the manufacturing site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. This site serves as a new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities of the position include maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and company’s compliance requirements at the onset of building the facility leading to successful . 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 of team’s Engineering functions ...