Quality Assurance Stability Coordinator

Stability Coordinator

Position Summary

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.

Greendale is one of Catalent’s gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers.  Simply put – we make healthy gummies. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The QA Stability Coordinator will report to the Compliance Manager. The QA Stability Coordinator is responsible for maintaining and running the stability program. This position is based on-site in Greendale, IN during normal business hours.

The Role

• Responsible for the organization, set-up and maintenance of stability databases

• Assist with the development of product submission QOS for existing and new development products (prepare and maintain stability summaries, stability data and specifications)

• Support Technical Services & WorkFront stability programs (placements and pulls) and occasionally commercial stability programs

• Perform bulk capsule testing on development bulk stability studies

• Review and prepare development SOP’s, Change Controls, etc related to scope of work.

• Review packaging specifications related to development stability studies (ie packaging quantities adequate to support study, correct configuration / components)

• Assist compliance department when required with agency and customer audit questions

• Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met

• Perform other duties as required

The Candidate

• HS Diploma or GED required. Bachelors degree in a science related field preferred.

• 1+ years of experience working with or managing relationships with regulatory bodies or related experience

• Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.

• Knowledge of local and federal regulations and ordinances

• Excellent computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word)

• Strong analytical skills and extremely detail oriented

• The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required.

• The employee is occasionally required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl.

• Vision abilities required by this job include close vision. ​

• The employee must regularly lift and /or move up to 30 pounds

Why You Should Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays ​

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 Care