Internship: Quality Assurance, Document Control

Catalent Pharma Solutions

Quality Assurance Internship

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

Catalyst + Talent

A 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 Catalent’s 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 support

The Role

The Quality Assurance department is responsible for all quality assurance and quality control functions at Catalent. The department’s 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, Document Control Intern responsibilities will include, but are not limited to the following:

  • Assist in the preparation of cGMP documents for transition into a new electronic document management system
  • Propose and assist in the implementation of quality improvements to document control systems
  • Review, issuance, and closure of Document Change Controls in accordance with Catalent’s SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model Work Orders, methods, etc.)
  • Audit SOP controlled files and SOP matrix for accuracy against CDMS System information
  • Audit Batch Record Suspension log to determine which Suspensions can be closed and driven to closure
  • Creation, distribution, closure and filing of logbook in tracker
  • Suspension paperwork organization and filing
  • Assist in the creation of training materials for job aids to make on-boarding training more robust and efficient
  • Creation of a trace-ability system for PDF renditions of controlled documents with respective source files visibility
  • Update databases (i.e. logbook tracking database) to align with off-site storage records to ensure prompt and fluid retrieval of controlled documents and records
  • Reduce risk by assisting in timely closure and filing of batch record suspensions

The Candidate

In 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, Computer Science or related field of study
  • Eligible to legally work in the United States
  • Work full time (40 hours/week) for a 10-12 week period

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 Develop s

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.
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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 [email protected] . 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.