Demo

Manufacturing Quality Expert

CSL Behring
Bradley, IL Full Time
POSTED ON 4/7/2025
AVAILABLE BEFORE 5/5/2025

Job Description

We are seeking a highly skilled professional to join our team as a Manufacturing Quality Expert. As a member of our Value Stream team, you will be responsible for ensuring the quality of our products and processes.

About the Role

The successful candidate will be responsible for:

  • Overseeing quality-related activities within a Value Stream, including operational quality oversight for the area and for the processes.
  • Ensuring adherence to applicable CSL standards and procedures via review and approval of related records.
  • Supporting and approving quality risk assessments, non-conformances, investigations, CAPAs, and change controls.
  • Monitoring and continuous improvement of quality performance metrics.
  • Partnering with all teams within the Value Stream regarding product quality aspects.

Main Responsibilities

  • Responsible for support and oversight of manufacturing shop floor quality, shop floor hygiene/sterility assurance.
  • Agency audit participation, including assisting in the presentation of quality investigations and decisions to health authorities.
  • Maintains a current status for department GMP training requirements and provides oversight to onboarding training to department personnel.
  • Accountable to manage all batch documentation review per unit operations and issue batch disposition recommendation within deviation investigations.
  • Requirements

    To be successful in this role, you will need:

    • A University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
    • 5 years' GMP experience in pharmaceutical/biotech/or other regulated industry
    • Experience within a global matrix organization
    • Knowledge of current Good Manufacturing Practices (cGMP) principles
    • Knowledge of appropriate regulatory requirements

    About CSL Behring

    CSL Behring is a global organization with employees in 35 countries. We are committed to the wellbeing of our employees and their loved ones, offering resources and benefits to support their needs.

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