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Senior Compliance Specialist - Quality Assurance Auditing

Company: Catalent Pharma Solutions, Inc.
Location: Morrisville
Posted on: May 5, 2021

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 Overview The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. The department is entirely separate from and independent of the personnel engaged in the direction and conduct of the project. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material and finished-product release. The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays. The Role

  • Manages and leads the Internal Audit program; includes preparing documents prior to the audit, creating PRs in Trackwise and managing audit during execution.
  • Coordinates and responds to Audit Letters or Observations.
  • Discuss observations with site leadership and applicable subject matter experts to determine corrective actions and responses and ensure compliance across site.
  • Support Customer Audit and Supplier Quality programs as required including execution and follow-up.
  • Identify potential compliance issues and task corrective measures to prevent them, participating on assigned teams as required. The Candidate
    • Bachelor's degree in chemistry or closely related physical science from a four-year college/university or equivalent education and job experience
    • 10+ years' experience in an FDA regulated industry and/or training is required
    • Previous experience interacting with Regulatory Agencies
    • Demonstrated experience performing audits ie. Customer, supplier, regulatory, internal, etc.
    • Previous experience with Supplier Quality is a plus
    • Broad knowledge and understanding of Quality Systems
    • Able to function independently with minimal supervision. Position Benefits
      • Medical, Dental, Vision and 401K are all offered from day one of employment
      • 19 days of paid time off annually + 8 paid holidays Leadership Competencies for Performance and Development
        • Leads with Integrity and Respect
        • Delivers Results
        • Demonstrates Business Acumen
        • Fosters Collaboration and Teamwork
        • Champions Change
        • Engages and Inspires
        • Coaches and Develops 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit to explore career opportunities. Catalent 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 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 Pharma Solutions, Inc., Cary , Senior Compliance Specialist - Quality Assurance Auditing, Other , Morrisville, North Carolina

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