Specialist III- Quality Assurance
Work Schedule: M-F 8am-5pm
100% on-site
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
Catalent Pharma Solutions in Madison, WI is hiring a Specialist III - Quality Assurance.
The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.
The Role:
Responsible for representing Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.
Lead continuous improvement projects for the Quality Assurance Operations department.
Accountable for review of Master Batch Production Records and material specifications for prepared solutions and columns.
Responsible for oversight of the control and management of Cell Bank inventory.
Provides review and approval of protocols and associated executed reports supporting Manufacturing operations, including media process simulations.
Responsible for review and approval deviation investigation records.
Develops and provides training to Quality Assurance and Manufacturing personnel on Quality topics.
Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
All other duties as assigned
The Candidate:
Doctorate Degree in STEM discipline with minimum of 6 years related experience.
OR
Master's Degree in STEM discipline with minimum of 8 years related experience.
OR
Bachelor's Degree in STEM discipline with minimum of 10 years related experience.
OR
Associates Degree in STEM discipline with minimum of 14 years related experience.
Prior work experience with quality management software such as TrackWise® or ComplianceWire®.
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
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 effective day one of employment
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
Championing the missions that matter™. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) and trusted partner to pharma, biotech, and consumer health companies worldwide. We put patients first in everything we do, helping people live better and healthier lives through every product we help develop, manufacture and deliver. With over 1,000 active development programs at any given time, we launch over 100 new products and line extensions annually. Catalent has supported half of all FDA approvals over the past decade, and our teams working at over 40 global sites help us produce over 60 billion doses every year.
Our strength lies in our people: teams across our more than 40 sites and thousands of passionate scientists and technicians who bring expertise in development sciences, delivery technologies, and multi-modality manufacturing. What unites us is our commitment to championing our partners’ missions as our own, anticipating customer needs, solving complex challenges and ultimately making a difference in the lives of patients across the globe.
At Catalent, you will be able to directly have an impact, solving problems and ensuring excellence for our customers. Our focus on delivering meaningful outcomes alongside our customers means your work directly impacts millions of people around the world. Join us in championing the missions that matter.
Catalent is headquartered in Tampa, Florida, with over 40 global sites. Visit www.catalent.com to learn more.
