Sr. Specialist, Quality Assurance

Planet Group
Newark, CA


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Job Summary:

The Sr. Specialist, Quality Assurance is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working in the Quality Systems team for providing quality oversight of the lifecycle management of GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. The individual will also provide support in maintaining the company’s Data Integrity Program. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs.

Reporting to: Sr. Manager, Quality Assurance

Location Newark, CA

Responsibilities/Essential Duties:
  • 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.
Skills:
Must be proficient in Microsoft Office applications

Education:
Minimum BS degree
Posted 2025-08-07

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