Quality Assurance Manager

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POST DATE 9/16/2017
END DATE 11/5/2018

AntriaBio, Inc. Louisville, CO

Louisville, CO
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


AntriaBio is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for Type 1 and Type 2 diabetes that addresses a $11 billion market where the current standard of care is a once-daily basal insulin injection.
Summary: The QA Manager is responsible for ensuring compliance to written procedures; establishing and maintaining quality systems; and providing GMP guidance to Operations and Quality Control.

Provide Quality oversight to ensure product is manufactured, tested, stored and distributed according to cGMPs and other applicable regulations
Support Quality Systems (Change Management, Document Control, Deviations/CAPA, Batch Record Review)
Support Facilities and Engineering with protocol and work order review/approval
Develop, implement and maintain phase appropriate Quality Systems
Perform internal and external Quality audits
Disposition materials
Draft and revise standard operating procedures
Oversight of maintenance and calibration program
Work cross functionally to achieve goals on tight timelines
Coaching of staff
Communicating clearly with staff and management team