Scientist I - Quality Control
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. Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
The Scientist I - Quality Control performs routine testing of process samples, raw materials, finished products, and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The Scientist I - Quality Control supports preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system.
Shift: Sunday-Wednesday 8 AM-6 PM
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role
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Independently executes and properly documents cGMP Quality Control testing.
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Independently operates basic and moderately complex cGMP Quality Control equipment. Accurately completes routing and preventive maintenance on basic to moderately complex equipment.
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Assists in authoring technical documents such as SOPs and reports.
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Performs self-review of analytical data for accuracy and consistency with SOP.
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Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
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Performs general lab housekeeping in adherence to 5S standards.
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Initiates and assists with records inn TrackWise.
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Other duties as assigned.
The Candidate
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Master's Degree in Biology, Biotechnology, Chemistry, or related life sciences field, OR Bachelor's Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 3 years of industry experience, OR Associates Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 6 years of industry experience, OR High School Diploma or equivalent with a minimum of 7 years of industry experience.
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Strong understanding of analytical chemistry and simple and moderately complex lab equipment preferred.
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Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
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cGMP, Good Documentation Practices (GDP), Good Laboratory Practices (GLP) knowledge, and experience following standard operating procedures (SOP) preferred.
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General laboratory equipment experience, including micropipettes.
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Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. Working conditions will be Heating Ventilation and Air Conditioned controlled.
Why You Should Join Catalent
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Several Employee Resource Groups focusing on D&I
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Tuition Reimbursement – Let us help you finish your degree or earn a new one!
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Generous 401K match
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152 hours accrued 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. 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.
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
