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Analyst, Quality System - Innovation

Company: CSL Behring
Location: Boca Raton
Posted on: November 19, 2022

Job Description:

Job DescriptionGENERAL SUMMARYThis position is responsible for analyzing quality performance of assigned business area.

  • Serves as the subject matter expert for US CSL Plasma quality systems for document and change management
  • Assists in the design, implementation, and delivery of quality systems and processes related to change and document management
  • Responsible for reviewing and monitoring quality metrics and reports for trends and opportunities for improvementsRESPONSIBILITIES
    • Recognized as a subject matter expert for CSL Plasma quality systems and processes. Explains to business stakeholders and end users the facts, policies, and practices related to document control and change management.
    • Ensure compliance to and successful use of the Quality Systems for Change Management. Conduct regular review of quality performance to ensure stable, high levels of compliance performance. Provide routine metric and KPI data for the management review quality systems metrics.
    • Manage assigned projects effectively with an emphasis on multi-tasking and the ability to meet deadlines with quality results. May lead or participate in cross-functional teams to meet project and other deadlines.
    • Supports evidence-based decision making and process improvement through data analysis. Evaluate areas for potential Process Improvements and implement strategies through project management and participation in key strategic projects. Analyze quality indicators and tack for trends against current standards for opportunities to improve. Coordinate and work closely with team members to identify, vet and implement best practices.
    • Monitor and analyze performance of quality systems and processes related to document and change management. Analyzes key performance metrics with dashboards for management use. Analyze data within defined criteria to assess impact or scope of notifications. Support quality oversight forums for change management. Prepare regular KPI reviews and provide surveillance metrics analysis to aid the remediation of identified issues and opportunities. Deliver trending data reports to assist in business decisions. Collaborate with cross-functional departments to optimize reporting capabilities.
    • Assists with the design, implementation and delivery of CSL Plasma programs through application of specialized knowledge and skills.
    • Monitor and maintain competency with the relevant quality systems, specifically DocNet and TrackWise that support plasma change processes.
    • Maintain a thorough understanding of the relevant regulations and guidelines, to include but not limited to FDA Good Manufacturing Practices, CSL corporation policies and procedures, GHA/EMA, and other applicable standards, such as ISO Quality Management Standards.
    • Establishes and maintains a good rapport with all functional groups and team members. Quickly engages with individuals involved in problems who need facilitation through to a successful resolution. Enables them to help themselves in future challenges through use of a disciplined approach to troubleshooting and documentation of steps taken.
    • Perform other duties as assigned to support business needs. - Promotes safety in all aspects of the position.JOB SPECIFICATIONSEducation
      • Requires a Bachelor's degree preferably in Business, Biology or related Health/Science field or equivalent combination of education, training and experience, minimum 4 years preferredExperience
        • Minimum 3 years' experience successfully serving in a Quality systems role preferable within an FDA or EMA, regulated industry experience required
        • Experience in change and document management within a regulated industry
        • Recognized individual contributor with technical expertise in quality systems
        • Develops, with all functional groups, stakeholder relationships with successful outcomes
        • Strong written and verbal communication, interpersonal and presentation skills
        • Excellent problem solving, decision-making, and system thinking skills
        • Strong ability to identify, monitor, and analyze process and/or system performance
        • Ability to learn new processes and quickly engage in assignments
        • Exercise good judgment to refer decisions to management when decisions fall out of the realm of established guidelinesWorking Conditions (physical & mental requirements)
          • Identifies problems, generally within own area of influence, and driven to collaborate and explore solutions
          • Ability to apply broad theoretical job knowledge of department processes
          • Ability to make decisions which may impact the department's creditability, operations and services
          • Ability to formulate comprehensive materials such as data analysis, system performance reports, etc. and/or make formal presentations
          • Ability to compose materials such as detailed reports, work-related manuals and/or make presentations within own work area
          • Approximately 80% of time spent sitting at the desk working on the computer, reading, or using phone
          • See, hear and speak with employees, vendors, and contractors
          • Overnight travel required up to 20% of the time
          • Work in fast paced environment with frequent interruptionsNote: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.About UsOur BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about at CSL.About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about .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 at CSL.Do work that matters at CSL Plasma!

Keywords: CSL Behring, Boca Raton , Analyst, Quality System - Innovation, Professions , Boca Raton, Florida

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