Quality Intern

Reposted 13 Hours Ago
Be an Early Applicant
Malvern, PA, USA
In-Office
Internship
Biotech • Pharmaceutical
The Role
Provide quality support for manufacturing operations, documenting processes, and assisting with investigations while ensuring compliance with regulations.
Summary Generated by Built In

Quality Intern

Position Summary

  • Shift: M-F 8am-5pm
  • 100% on-site

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The QA Co-op is responsible for the Quality support functions associated with the manufacturing. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent  SOP)  through  document review/approval and real time monitoring/approval of manufacturing activities

The role:

  • Organize and update Quality documents and production records to ensure documentation is accurate and complete
  • Support document lifecycle activities including routing, revision control, and archiving
  • Review draft SOPs and batch record updates for formatting accuracy and required field completion
  • Support the review of batch records and manufacturing documentation
  • Assist with room and equipment clearance checks following cleaning (training provided)
  • Assist QA staff with investigations and quality deviation assessments by gathering and reviewing data
  • Participate in team meetings and support cross-functional quality improvement projects

The candidate:

  • Sophomore in Life Sciences, Health Sciences, or Engineering preferred; prior co-op experience a plus
  • Demonstrates initiative and is a self-starter with a willingness to learn
  • Excellent verbal and written communication skills
  • Detail-oriented and highly organized
  • Strong time management and ability to work with limited supervision on routine tasks
  • Sound decision-making, technical, and problem-solving skills
  • Understanding of lab or GMP concepts preferred (coursework acceptable)

Why you should join Catalent:

  • Dynamic, fast-paced work environment
  • Opportunity to work on Continuous Improvement Processes

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 Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Top Skills

Cfr
Cgmp
Sop
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The Company
HQ: Somerset, NJ
13,715 Employees
Year Founded: 2007

What We Do

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.

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