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Quality Systems Specialist

Company: CSL Behring
Location: Kankakee
Posted on: November 24, 2022

Job Description:

Job DescriptionCSL Behring in Kankakee, Illinois has grown into a global biotechnology leader driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded America's Best Employer for 2022 by Forbes magazine thus offer an exciting opportunity to join CSL as Quality Systems Analyst.Quality Systems SpecialistKey Responsibilities:This role requires proficiency in Document and Records systems, with potential to become proficient in the Learning System.General

  • Ensure system related tasks follow policies and procedures
  • Provide Systems support for local customers to ensure efficient operations and compliance with GxP standards
  • Collate reports and communicate site key performance indicators
  • Train users in system functions
  • Support authority/customer inspection documentation requestsDocument Systems
    • Action document change management process (formatting documents, setting effective dates, control approvals, coordinate timelines, manage periodic review assignment)
    • Responds to Disaster recovery incidencesRecords Systems
      • Action Archives activities (including conservation considerations, checking contents, managing loans, destructions, Legal Holds)
      • Action Records activities in records management systemKey Interactions
        • Site functions and external parties (including Seqirus, blood agencies)Education:
          • Undergraduate degree in related discipline or relative experience is preferredQualifications:
            • Technical expertise in pharmaceutical quality systems and quality management processes
            • Microsoft applications
            • Knowledge of GxPs, FDA & EMEA Regulations governing validated applications including 21CFR Part 11 is an advantage
            • Strong organizational skill and able to manage fine details across multiple priorities
            • Able to manage busy, diverse work portfolio
            • Strong communication skillsAbout UsOur BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.Do work that matters at CSL Behring!

Keywords: CSL Behring, Joliet , Quality Systems Specialist, Other , Kankakee, Illinois

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