New · posted Nov 13
Catalent · Biotechnology
Specialist, QA OTF
- Princeton, NJ
- On-site
- Full-time
- Associate & Specialist
The role
We have an opportunity for a Specialist, QA OTF to join our team supporting GMP manufacturing of master and working cell banks, biological bulk drug substances, and finished drug products for human use. The role provides real-time quality oversight, documentation review, deviation management, and compliance monitoring to ensure product quality and patient safety. The Specialist will work closely with manufacturing and support teams to maintain high standards of GMP compliance and continuous improvement. This position reports to the Manager, QA.
Shift: Monday - Friday, 8am - 5pm
Location: Princeton, NJ
100% Onsite
- Partner with Manufacturing and cross-functional teams, maintaining a strong floor presence (approximately 80%) to support GMP operations and ensure real-time quality oversight.
- Perform QA on-the-floor activities, including room release, observation of critical manufacturing processes, issue resolution, and real-time batch record review.
- Conduct routine audits and walkthroughs of manufacturing, warehouse, and support areas to verify compliance, equipment readiness, material control, labeling, and housekeeping standards.
- Monitor adherence to cGMP requirements, Quality Management System procedures, aseptic behaviors, and Good Documentation Practices.
- Review manufacturing documentation and batch records for accuracy, compliance, and contemporaneous completion using controlled documents.
- Provide QA oversight for the manufacture of cell banks, drug substances, and final drug products, including Acceptable Quality Limit (AQL) visual inspections.
- Make independent quality decisions, identify risks, escalate issues appropriately, and drive continuous improvement initiatives.
- Serve as a quality resource to GMP personnel by providing guidance on compliance, regulatory requirements, internal procedures, and industry best practices.
- Build effective partnerships across operations and support functions to strengthen quality culture and operational excellence.
- Ensure timely completion of projects, documentation, and quality deliverables while maintaining professionalism and effectiveness in a dynamic team environment.
What you need
Minimum Requirements
- High school diploma or General Educational Development required; Bachelor’s degree preferred.
- 2+ years of experience within the biologic, biopharmaceutical, or regulated industry.
- Knowledge or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
- Strong knowledge of Good Manufacturing Practices, 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
- Creative and adaptable professional with strong troubleshooting, decision-making, and communication skills; able to quickly learn new manufacturing processes, interpret evolving global regulations, and deliver results independently or collaboratively in fast-paced GMP environments while effectively engaging personnel at all levels, including regulatory inspectors.
- Ability to work extended periods while standing or sitting in Grade B gowning, perform documentation and computer-based tasks, and meet required visual acuity and color vision standards.
- Capable of handling physical demands including lifting or pushing up to 50 lbs., working in confined spaces, and performing cleaning activities using disinfectants, sporicidal agents, and specialized equipment.
- Comfortable working in GMP manufacturing environments with exposure to human blood components, biohazardous materials, moving mechanical equipment, and other controlled operational hazards.
- Work performed in grade A BSC or grade B, C, or D controlled environments with full gowning requirements and aseptic techniques.
Preferred Skills & Backgroundnice to have
- 1+ years of experience in Manufacturing, Quality Assurance, or Quality Control preferred.
- Knowledge of pharmaceutical regulations relating to biologics preferred.
- Experience or knowledge in Trackwise preferred.
- Experience or knowledge with electronic batch records preferred.
Skills named in this posting
Pay and benefits
$85,000 – $95,000 a year
Employer providedThe anticipated salary range for this position in NJ is $85,000 – $95,000 plus bonus. The final salary offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs. Catalent is a multi-state employer, and this range may not reflect positions in other states.
Medical, dental, and vision benefits from day one
Competitive paid time off
8 paid holidays
Tuition reimbursement program
Annual bonus
Career growth opportunities
Where you'll work
Princeton, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Princeton, NJ
From the posting
About Catalent
About Site
Catalent’s Princeton, New Jersey site is a key part of the company’s cell therapy network and serves as a U.S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late‑stage clinical development, process characterization, and commercial‑scale CGMP manufacturing across a wide range of cell types. With flexible cleanroom suites, quality control laboratories, and an experienced technical team focused on scalable, single‑use manufacturing approaches, the Princeton site enables reliable production and supply of advanced cell‑based therapies. As part of Catalent’s global Cell & Gene Therapy organization, the Princeton facility plays a strategic role in helping partners advance complex, personalized medicines toward commercialization.
Why You Should Join Catalent
- Defined career path with annual performance reviews and feedback.
- Diverse and inclusive culture.
- Opportunities for career growth within an organization dedicated to improving lives.
- Competitive paid time off plus 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective on day one of employment.
- Tuition reimbursement program.
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 · November 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $85,000 | — | $95,000 |
| All US (middle half) | $80,125 | $88,000 | $96,125 |
This role: Catalent's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 109 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Catalent's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Documentation and SOPs8
- Collaboration and leadership4
- Quality systems and risk3
- Data and digital systems2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validationNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Catalent on Regulatory Jobs
- 38
- Open roles
- 38
- Distinct roles
- 8
- Locations
By discipline
- Quality37 97%
- Regulatory1 3%
By level
- Associate & Specialist17 45%
- Senior & Principal14 37%
- Manager5 13%
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Specialist, QA OTF at Catalent
Applications close December 14. $85K–$95K a year, employer provided.