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 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
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Responsible for the organization, set-up and maintenance of stability databases
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Assist with the development of product submission QOS for existing and new development products (prepare and maintain stability summaries, stability data and specifications)
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Support Technical Services & WorkFront stability programs (placements and pulls) and occasionally commercial stability programs
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Perform bulk capsule testing on development bulk stability studies
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Review and prepare development SOP’s, Change Controls, etc related to scope of work.
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Review packaging specifications related to development stability studies (ie packaging quantities adequate to support study, correct configuration / components)
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Assist compliance department when required with agency and customer audit questions
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Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
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Perform other duties as required
The Candidate
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HS Diploma or GED required. Bachelors degree in a science related field preferred.
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1+ years of experience working with or managing relationships with regulatory bodies or related experience
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Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
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Knowledge of local and federal regulations and ordinances
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Excellent computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word)
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Strong analytical skills and extremely detail oriented
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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.
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The employee is occasionally required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl.
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Vision abilities required by this job include close vision.
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The employee must regularly lift and /or move up to 30 pounds
Why You Should Work At Catalent
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Spearhead exciting and innovative projects
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Fast-paced, dynamic environment
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High visibility to members at all levels of the organization
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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 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.
What We Do
Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.
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.
Visit https://careers.catalent.com/us/en to explore career opportunities
