New · posted Oct 20
Catalent · Biotechnology
Senior Associate I - Quality Assurance
- Madison, WI
- On-site
- Full-time
- Senior & Principal
Closes Nov 19, 2026 · 30 days left
The role
- Work Schedule: Monday-Friday 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 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 Senior Associate I - Quality Assurance Operations.
The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.
- Accountable for execution of the QA on the Floor program.
- Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting when problems arise.
- Provides direct quality support for routine manufacturing operations.
- Responsible issuance of controlled documents for production, including Batch Production Records,
Product Labels and forms. - Responsible for review of documentation, including batch records, test data, environmental monitoring data, and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance.
- Performs release of produced solutions and columns.
- Assists with inspection of final product containers
- Supports shipment of finished products.
- Responsible for review of facility and equipment records in support of GMP operations.
- Accountable for control and management of Cell Bank inventory
- Notifies Management of potential quality or regulatory issues that may affect product quality or
regulatory compliance. - Perform or support any other tasks necessary to maintain the product quality and site CGMP compliance.
- Files and maintains controlled documents.
- Other duties as assigned.
What you need
3 ways to qualify
Master’s
+ 0+ years of experience
Master’s degree in STEM discipline with minimum of 0 years related experience.
OR- or
Bachelor’s
+ 3+ years of experience
Bachelor's Degree in STEM discipline with minimum of 3 years related experience.
OR - or
High school
+ 7+ years of experience
High School Diploma with a minimum of 7 years related experience.
The Candidate
- Associates Degree in STEM discipline with minimum of 6 years related experience.
OR
Pay and benefits
Catalent didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
152 hours of PTO and 8 paid holidays
401K match
Medical, dental and vision benefits from day one
Tuition reimbursement
Defined career path with annual performance review
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 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.
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 20, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US297 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $102,500 | $119,000 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 889 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 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance5
- Documentation and SOPs5
- Collaboration and leadership2
- Lab testing and methods1
- Regulatory submissions1
- 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.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Catalent on Regulatory Jobs
- 30
- Open roles
- 28
- Distinct roles
- 8
- Locations
By discipline
- Quality30 100%
By level
- Associate & Specialist12 40%
- Senior & Principal10 33%
- Manager6 20%
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Senior Associate I - Quality Assurance at Catalent
Applications close November 19.