Sr. Specialist, Quality Assurance
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- Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products.
- Coordinate and track closure of quality records such as change controls, deviations, CAPAs, quality investigations, etc.
- Provide quality oversight for Facilities/Utility System/Equipment (FUSE) Qualification, Analytical Instrument Qualification (AIQ) and Computerized Systems Validation/Assurance(CSV/CSA) and applies risk-based methodology to validation/qualification efforts in accordance with current regulatory requirements and industry guidance.
- Provide quality oversight for System and Equipment implementation activities related to Analytical Development method project.
- Provides quality oversight of steady state activities and quality records (deviations, CAPAs, and changes controls) for GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems.
- Drive data integrity awareness and maintain the Data Integrity Program to ensure compliance and reliability across the data lifecycle for GxP Operations.
- Support continuous improvement of quality systems by authoring new or revising existing department procedures and/or forms.
- Other duties as assigned.
Must be proficient in Microsoft Office applications Education:
Minimum BS degree
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