New · posted Oct 25
Catalent · Biotechnology
Specialist III – Quality Assurance, Systems
- Madison, WI
- On-site
- Full-time
- Senior & Principal
The role
- Work Schedule: M-F 8am-5pm
- 100% on-site
Catalent’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.
- Perform quality review and approval on deviations, laboratory investigations, and complaints
- Oversee Corrective and Preventive Actions (CAPAs) opened in response to deviations
- Address client comments on investigations
- Participate in client calls to discuss investigation status
- Engage in customer contact as required
- Provide technical assistance and training for personnel
- File and maintain controlled documents
- All other duties as assigned.
What you need
4 ways to qualify
PhD
+ 6+ years of experience
Doctorate Degree in a STEM discipline with a minimum of 6 years of related experience
- or
Master’s
+ 8+ years of experience
OR Master’s Degree in a STEM discipline with a minimum of 8 years of related experience
- or
Bachelor’s
+ 10+ years of experience
OR Bachelor’s Degree in a STEM discipline with a minimum of 10 years of related experience
- or
Associate
+ 14+ years of experience
OR Associate’s Degree in a STEM discipline with a minimum of 14 years of related experience
The Candidate
Pay and benefits
Catalent didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Medical, dental, and vision benefits effective day one
Competitive paid time off
8 paid holidays
Tuition reimbursement
Defined career path with annual performance reviews
Community engagement and green initiatives
Where you'll work
Madison, WIOn-siteOpen in Maps (opens in a new tab)
More jobs in Madison, WI
From the posting
About Catalent
Why you should join Catalent
- Defined career path with annual performance reviews and feedback process
- Diverse and inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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.
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.
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.
Equal opportunity, accessibility and legal noticesCatalent's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US323 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $104,000 | $122,000 | $142,250 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Catalent's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA5
- GMP and compliance2
- Collaboration and leadership2
- Lab testing and methods1
- Documentation and SOPs1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Catalent on Regulatory Jobs
- 34
- Open roles
- 31
- Distinct roles
- 8
- Locations
By discipline
- Quality34 100%
By level
- Senior & Principal13 38%
- Associate & Specialist13 38%
- Manager6 18%
More roles at Catalent
- View role
Commercial Manufacturing Quality Assurance Specialist
Kansas City, MOAssociate & SpecialistPharmaceuticalsSalary not listed
- View role
Associate, Quality Assurance
Kansas City, MOAssociate & SpecialistPharmaceuticalsSalary not listed
- View role
2027 Intern - QA, QMS
Madison, WIAssociate & SpecialistBiotechnologySalary not listed
- View role
Senior Associate I - Quality Assurance
Madison, WISenior & PrincipalBiotechnologySalary not listed
Similar Quality Assurance roles elsewhere
- View role
Senior Quality Assurance Specialist, Material Supplier
RegeneronRensselaer, NYSenior & PrincipalBiotechnology$67K–$129K
- View role
Senior Staff AI Engineer, AI Quality & Test Automation
IlluminaSan Diego, CASenior & PrincipalBiotechnology$142K–$212K
- View role
Senior Quality Assurance Specialist
RegeneronEast Greenbush, NYSenior & PrincipalBiotechnology$79K–$129K
- View role
Sr QA Reviewer, Biologics Approval
Thermo Fisher ScientificFoster City, CASenior & PrincipalBiotechnology$85K–$94K
Specialist III – Quality Assurance, Systems at Catalent
Applications close November 23.