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Prior Authorization
Overview:
- Responsible for managing GxP quality requirements.
- Partnering with CMC and Commercial Operations to ensure product compliance.
- Support Quality Assurance processes for clinical stage programs.
Principle Duties and Responsibilities:
- Review of executed records and final Product Disposition.
- Provides the Quality oversight to ensure product is manufactured.
- Authors new or revisions to quality systems SOPs and work instructions.
Qualifications/Requirements:
- Minimum of Bachelor’s degree in a scientific discipline.
- Strong knowledge of appropriate Quality Systems and cGMPs.
- Strong verbal skills, technical writing skills and ability to work with others in a collaborative manner.
Rezolute
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). They are working to treat all forms of HI. More information can be found at rezolutebio.com