Quality Systems Specialist

Employment Type

: Full-Time

Industry

: Miscellaneous



The Role

  • Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution.
  • Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a
    routine basis.
  • Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements.
  • Administer the Change Control process for the site and conduct effectiveness verification for changes implemented. 
  • Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization
  • Continuously monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices.
  • Coordinates on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations. 
  • The Candidate

  • Minimum of a B.S. in a Life Sciences discipline
  • 6 years’ experience in a GMP environment with at least 4 of those years in a Quality/Compliance function
  • Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
  • ASQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) highly desirable
  • Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

  • Position Benefits

  • Potential for career growth within an expanding team
  • Defined career path and annual performance review & feedback process
  • Cross functional exposure to other areas of within the organization 
  • Medical, Dental, Vision, and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays

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