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Quality Systems Specialist

Company: Catalent
Location: Severn
Posted on: March 22, 2020

Job Description:

Job Description Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Quality Systems Specialist Position Summary Catalent Paragon Gene Therapy is looking to recruit a Quality Systems Specialist to join our growing team in Harmans, MD.The Quality Systems Specialist responsible for supporting Quality Systems, including investigation/deviation management, CAPA tracking, and change control. This position will facilitate the compiling, trending and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. The Quality Systems Specialist role is critical to our patients. Ensuring compliance with quality systems with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!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 aroutine 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 desirableCatalent'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 DevelopsPosition 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 Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities. C atalent is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to (see below) . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Keywords: Catalent, Severn , Quality Systems Specialist, Other , Severn, Maryland

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