New · posted Oct 28
Catalent · Pharmaceuticals
Commercial Manufacturing Quality Assurance Specialist
- Kansas City, MO
- On-site
- Full-time
- Associate & Specialist
The role
We have an opportunity for a Commercial Manufacturing Quality Assurance Specialist to join our team. In this role, you will support quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining high standards of product quality. You will contribute to continuous improvement initiatives and collaborate with cross-functional teams to uphold regulatory and internal standards. This position offers the chance to make a meaningful impact in a dynamic, science-driven environment.
Shift: M-F 6am-2pm
Location: Kansas City, MO
100% Onsite
- Perform batch record review, product release, and disposition.
- Draft, review, and approve technical documents such as procedures or master batch records.
- Ensure that products are manufactured, tested, and released according to applicable FDA guidelines, regulations, GXPs, and internal standard operating procedures.
- Participate in the development and maintenance of quality assurance programs, procedures, and controls to ensure that products meet established standards and agency guidelines.
- Train, coach, and mentor others on technical, personal development, or business issues.
- Assist in data compilation for annual product review.
- Provide quality assurance advisement for project outcomes and customer interactions.
- Participate in the development and implementation of process-related improvements.
- Assist with manufacturing floor activities, including equipment and room approval and facility compliance.
- Perform other duties as assigned.
What you need
Minimum Requirements
- Master’s degree in a scientific discipline with no experience, or Bachelor’s degree in a scientific discipline with 1+ years of experience in Quality Assurance, Quality Control, or Regulatory Compliance in a Good Manufacturing Practice environment, or Associate’s degree with 3+ years of experience in an FDA-regulated field and 1+ years in Quality Assurance, Quality Control, or Regulatory Compliance, or high school diploma with 5+ years of experience in an FDA-regulated field and 1+ years in Quality Assurance, Quality Control, or Regulatory Compliance.
- Six Sigma or American Society for Quality certification preferred.
- Perform batch record review, product release, and disposition.
- Draft, review, and approve technical documents such as procedures or master batch records.
- Participate in the development and maintenance of quality assurance programs, procedures, and controls to ensure that products meet established standards and agency guidelines.
- Provide quality assurance advisement for project outcomes and customer interactions.
- Participate in the development and implementation of process-related improvements.
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 plus 8 paid holidays
Tuition reimbursement
Defined career path with annual performance review
Community engagement and green initiatives
Where you'll work
Kansas City, MOOn-siteOpen in Maps (opens in a new tab)
More jobs in Kansas City, MO
From the posting
About Catalent
About Site
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Why You Should Join Catalent
- Defined career path and annual performance review and feedback process.
- Diverse, 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
Associate & Specialist roles in the US181 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $81,000 | $95,500 |
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 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs8
- GMP and compliance4
- Regulatory submissions2
- Collaboration and leadership2
- 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
- 34
- Open roles
- 31
- Distinct roles
- 8
- Locations
By discipline
- Quality34 100%
By level
- Senior & Principal13 38%
- Associate & Specialist13 38%
- Manager6 18%
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Commercial Manufacturing Quality Assurance Specialist at Catalent
Applications close November 27.