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Associate II - Quality Assurance
full-timeMadison

Summary

Location

Madison

Type

full-time

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About this role

Associate II - Quality Assurance

Position Summary:

  • Work Schedule: Monday - Friday, 8:00am to 5:00pm CST
  • 100% on-site

Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. site offers integrated formulation and analytical services to address complex development challenges in biologics.

The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.

The Role:

  • Execution of the Document Management System
  • Manages physical and electronic storage of documents
  • Assures integrity of controlled master documents and executed records
  • Assists with document retrieval during customer audits
  • Performs scanning and filing
  • Other duties as assigned

The Candidate:

  • Must have Bachelor's Degree, preferably in a STEM discipline with minimum of 1 years related experience OR Associate’s Degree, preferably in a STEM discipline with minimum of 4 years related experience OR High School Diploma with a minimum of 6 years related experience.
  • Must have a basic understanding of pharmaceutical laboratory and/or production operations
  • Must be detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
  • Proficiency in MS Office is required

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process 
  • Diverse, inclusive culture 
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match 
  • Medical, dental and vision benefits
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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 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.

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 spam@catalent.com for us to investigate with local authorities.

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

Other facts

Tech stack
Document Management,Detail Oriented,Organizational Skills,MS Office Proficiency,Pharmaceutical Knowledge

About Catalent

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.
Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

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 life.

Grow with us. Be challenged. Make a personal impact.

Team size: 10,001+ employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing
Founding Year: 2007

What you'll do

  • The role involves executing the Document Management System, managing the storage of documents, and ensuring the integrity of controlled master documents. Additional tasks include assisting with document retrieval during audits and performing scanning and filing.

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Frequently Asked Questions

What does a Associate II - Quality Assurance do at Catalent?

As a Associate II - Quality Assurance at Catalent, you will: the role involves executing the Document Management System, managing the storage of documents, and ensuring the integrity of controlled master documents. Additional tasks include assisting with document retrieval during audits and performing scanning and filing..

Why join Catalent as a Associate II - Quality Assurance?

Catalent is a leading Pharmaceutical Manufacturing company.

Is the Associate II - Quality Assurance position at Catalent remote?

The Associate II - Quality Assurance position at Catalent is based in Madison, Wisconsin, United States. Contact the company through Clera for specific work arrangement details.

How do I apply for the Associate II - Quality Assurance position at Catalent?

You can apply for the Associate II - Quality Assurance position at Catalent directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Catalent on their website.