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QA Manager, Deviations and CAPA

Company: Just - Evotec Biologics
Location: Redmond
Posted on: May 7, 2022

Job Description:

Just-Evotec Biologics is seeking a highly motivated QA Manager within the Quality Operations group that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for overseeing the end-to-end management lifecycle for the Deviation, Nonconformance, and CAPA records and overseeing the programs from a quality perspective.Responsibilities:

  • Overall responsibility for deviation and CAPA management programs.
  • Working with functional areas to determine actions to gather data and investigation content.
  • Participating in client communication around deviations and investigations.
  • Root cause analysis and classification, development of effective CAPA to address root causes.
  • Preparing deviation records for review and approval.
  • Monitoring and tracking performance metrics related to deviations and CAPAs.
  • Participate in and help implement deviation and compliance improvement projects, including SOP revisions and Change Control management.
  • Providing input on the development of personal performance goals.
  • Train internal groups on relevant business processes.
  • Perform tasks as requested by leadership to support Quality oversight activities.Qualifications and Educational Requirements
    • B.S. or M.S. degree, preferably in Engineering, Life Science, or an equivalent combination of education and experience in the Biopharmaceutical Industry.
      • 5+ years of relevant experience in a Biopharmaceutical cGMP manufacturing or similar environment. Previous experience with writing and/or review of deviation and CAPA records preferred.
      • Sound knowledge of cGMPs and Document Control guidelines set forth in ICH Q7 and Q10.
      • Knowledgeable user of Root Cause Analysis tools (5 Why, Fishbone, etc.)
      • Experience with GMP biologics manufacturing processes and equipment.
      • Ability to communicate issues, ideas, and results clearly and professionally in a comprehensive and concise manner both verbally and in writing. Ability to explain complex issues and concepts with simplicity to a broad audience.
      • Ability to guide staff and provide leadership across all levels of the organization.
      • The ability to work both independently and collaboratively with scientific, operational, quality, and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
      • Significant experience navigating and managing various modules in a Quality Management System software suite.
        • Strong focus on Quality and attention to detail.Middle Management

Keywords: Just - Evotec Biologics, Redmond , QA Manager, Deviations and CAPA, Executive , Redmond, Washington

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