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Quality Delegate

Company: CSL Behring
Location: Kankakee
Posted on: November 19, 2021

Job Description:

About UsWith operations in 35+ nations and -27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionPosition Purpose: This role is responsible for:

  • The quality oversight for changes within the Value Stream, providing the review and approval of change controls, release to operations, and the closure.This role will partner closely with the Quality Systems Manager - Change Control and other Quality Delegates to continuously improve and standardize the change control process across the site.Principal Accountabilities:
    • Responsible for the quality oversight to all changes within respective Value Streams, ensuring change is fully developed and documented clearly, with appropriate actions and supporting documentation in place to support the change; Understanding Validation and Regulatory strategies in place to support the change.
      • Responsible for reviewing document changes that are within scope of change controls, ensuring documentation from both eQMS are accurate and complete; Assists with the determination if document changes require a change control or just document only changes.
        • Collaborate with Change Owners within Value Streams, as well as other areas as necessary, to assist with development of change controls.
          • Collaborates with the Global QMS Operations team to schedule changes to be presented at the Global Change Panel meetings, as necessary.
            • Assists QA Value Stream Lead in identifying potential change control issues with process/system, and communicating with Compliance.
              • Participates in site Change Review Board and the Value Stream Change Review Board for respective Value Stream.
                • Responsible for reviewing MES changes to eMBRs as part of the change control process.
                  • Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.
                    • Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
                      • Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
                        • Completes any other duties/responsibilities assigned by senior management.Education:
                          • Undergraduate degree in relevant discipline (or equivalent)Related Experience:
                            • 2 years or more years industry experience
                            • Significant technical expertise in:
                              • Change Management
                              • Change Control
                                • Knowledge of cGMPs and FDA guidelines required
                                • Demonstration competency of verbal and written communication

Keywords: CSL Behring, Joliet , Quality Delegate, Other , Kankakee, Illinois

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