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Internship: Quality Assurance, Compliance and Audits

Company: Catalent Pharma Solutions
Location: Saint Petersburg
Posted on: February 16, 2020

Job Description:

Job DescriptionPosition Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalents 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 hereCatalyst + TalentA Catalent internship offers you countless opportunities to have direct impact on the health and well-being of millions of people globally! Your passion for learning coupled with Catalents superior technologies will help drive the advancement of medicine in collaboration with leading pharmaceutical, biotech and health care innovators. The Catalent Internship Experience includes

  • Opportunity to make an impact in the lives of patients all over the world!
  • Experience through hands-on projects that support more superior drug development and delivery technologies than anyone else.
  • Exposure to top-tier scientists and industry leaders
  • Commitment from dedicated managers and mentors who are advocates for your success and career development
  • Access to collaborative and highly engaged colleagues across the globe excited to share their knowledge and provide you supportThe Role The Quality Assurance department is responsible for all quality assurance and quality control functions at Catalent. The departments primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing.The Quality Assurance, Compliance and Audits Intern responsibilities will include, but are not limited to the following:
    • Assist with customer audit preparation including the printing of documentation, logs, etc. and coordinating walkthroughs as necessary
    • Act as scribe in the audit room for record maintenance during customer audits
    • Act as a runner in the audit room during customer audits to retrieve requested documentation as required
    • Assist with drafting communication/responses to customer audits and inquiries
    • Assist with internal audits acting as an auditor (training and time permitting)
    • Assist with audit action metrics and development of additional tables/reports as needed
    • Assist with audit action follow-ups (training and time permitting)
    • Assist with requests for completion of quality questionnaires
    • Assist with requests for information from internal regulatory affairs team
    • Assist in revamp of Customer and Regulatory PowerPoint presentationsThe CandidateIn order to be eligible for an internship at Catalent, you must meet the following requirements:
      • Currently enrolled in a College or University
      • Must be an undergraduate/graduate student in Life Sciences or a related field of study
      • Eligible to legally work in the United States
      • Work full time (40 hours/week) for a 10-12 week periodCatalents 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 DevelopsCatalent 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 www.catalent.com/careers 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 DisabilityAccommodations@catalent.com. 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.Catalent = Catalyst + TalentYour talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!personal initiative. dynamic pace. meaningful work.Catalent is the perfect place to grow your career if
          • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
          • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year more than any branded drug maker in the world!
          • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
          • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
          • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
          • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here. 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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Keywords: Catalent Pharma Solutions, St. Petersburg , Internship: Quality Assurance, Compliance and Audits, Accounting, Auditing , Saint Petersburg, Florida

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