Specialist III - Quality Assurance, Systems

Specialist III – Quality Assurance, SystemsPosition Summary:Work Schedule: M-F 8am-5pm100% on-siteCatalent's Madison, Wisconsin site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single-use systems to enable rapid scale-up and customization. The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high-yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent's global biologics network and Wisconsin's growing life sciences ecosystem.We have an opportunity for a Specialist III – Quality Assurance, Systems to join our team. This role is accountable for the Investigation and CAPA Management Systems. You will manage complex and high-level deviations, support Out-of-Specification investigations, and collaborate with internal stakeholders to ensure effective execution of these systems. The position also focuses on maintaining and improving Quality Systems, reporting metrics, and implementing process enhancements to support compliance and operational excellence.The Role:Perform quality review and approval on deviations, laboratory investigations, and complaintsOversee Corrective and Preventive Actions (CAPAs) opened in response to deviationsAddress client comments on investigationsParticipate in client calls to discuss investigation statusEngage in customer contact as requiredProvide technical assistance and training for personnelFile and maintain controlled documentsAll other duties as assigned.The Candidate:Doctorate Degree in a STEM discipline with a minimum of 6 years of related experienceOR Master's Degree in a STEM discipline with a minimum of 8 years of related experienceOR Bachelor's Degree in a STEM discipline with a minimum of 10 years of related experienceOR Associate's Degree in a STEM discipline with a minimum of 14 years of related experienceWhy you should join Catalent:Defined career path with annual performance reviews and feedback processDiverse and inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent 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 View email address on click.appcast.io. 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 View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.