Senior Quality Assurance Specialist

Added
18 days ago
Type
Full time
Salary
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Related skills

quality assurance data integrity gxp gmp capa

๐Ÿ“‹ Description

  • Perform a wide variety of quality assurance activities to ensure compliance with Revance
  • Coordinate and track closure of quality records such as change controls, deviations, CAPAs, quality
  • Provide quality oversight for Facilities/Utility System/Equipment (FUSE) Qualification, Analytical
  • Provide quality oversight of the Information & Technology (IT) Department.
  • Provides quality oversight of steady state activities (System Audit Trail Reviews, User Account
  • Drive data integrity awareness and maintain the Data Integrity Program to ensure compliance and

๐ŸŽฏ Requirements

  • BS or equivalent in biology, chemistry or related science or equivalent experience
  • Minimum of 6 years of experience in the pharmaceutical or biotechnology industry with at least 4 of
  • Good working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and
  • Good interpersonal and verbal and written communication skills
  • Experience in aseptic processes is highly desirable and knowledge of biologics is a plus
  • Ability to manage multiple clinical projects

๐ŸŽ Benefits

  • Competitive Compensation including base salary and annual performance bonus
  • Flexible PTO (12 days' PTO), holidays, and parental leave
  • Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance
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