Specialist QA, Product Disposition

Juno Therapeutics Bothell , WA 98021

Posted 3 months ago

The Quality Assurance Product Disposition team at Juno is responsible for overseeing and supporting Product Disposition operations at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Specialist, QA is responsible for conducting the disposition of raw materials and finished drug products.

Primary Responsibilities include:

  • Conduct routine lot disposition activities for finished drug products by ensuring all relevant documentation associated with a lot are accounted for, completed and approved.

  • Review and approve the QC documentation related to each lot (Certificate of Analysis and QC testing data, including EM and analytical data)

  • Review and disposition materials used in the manufacture of drug products

  • Perform the review of lot genealogy for all raw materials and components used in each lot to ensure they are approved and released using the electronic system (Manufacturing Execution System)

  • Conduct the lot disposition process and ensure the Dosage assignment is reviewed and approved by the appropriate individuals

  • Collaborate with stakeholders and management, and communicate lot disposition status; monitor progress and issue status reports

  • Assemble and review Quality system documents such as, deviations, LIRs, batch production records, test methods, specifications, and controlled forms associated with each lot for disposition

  • Create and revise relevant Standard Operating Procedures (SOP) as needed

  • Support internal and external audit activities and other QA department needs as identified by management

REQUIRED QUALIFICATIONS

  • Minimum of 6+ years working in a QA role within a commercial biopharmaceutical, cellular therapy, or gene therapy organization

  • Knowledge of CGMP regulations and FDA guidances applicable to biologics and cell therapy

  • Detail oriented, with strong good documentation practices expertise

  • Direct experience with disposition supporting the manufacturing, testing, disposition, and distribution of CGMP products

  • Excellent communication, trouble shooting, and problem solving skills

  • Strong team player that can also work independently to achieve objectives

EDUCATION REQUIREMENTS

  • Bachelor's degree in a life science discipline
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Specialist QA, Product Disposition

Juno Therapeutics