New · posted Nov 4
Catalent · Pharmaceuticals
Quality Control Analyst
- Winchester, KY
- On-site
- Full-time
- Associate & Specialist
The role
- Typical working hours are Monday-Friday 11 PM - 7:30 AM (begins Sunday night at 11 PM and goes through Friday morning at 7:30 AM)
- This position is 100% on-site in Winchester, Kentucky.
Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.
The Quality Control Analyst performs the basic and critical experimental work of day-to-day analysis, including generation and analysis of data. The Quality Control Analyst works “hands on” in an analytical lab that requires analytical testing, computer operating, record keeping, and report writing abilities.
- Perform efficient/reliable/high quality analytical testing in accordance with USP/NF/EP/JP/FCC/etc. or customer supplied guidelines. Typical testing may include Dissolution, Titration, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC, etc.
- Maintain accurate written records of all analysis performed.
- Accurately interpret and effectively communicate analytical results and issues.
- Schedule daily tasks in an organized and efficient manner.
- Calibrate and maintain lab equipment and instrumentation.
- Responsible for operating in a safe manner, must be familiar with basic laboratory and chemical hygiene practices
- Perform peer review of analytical testing and write up. Write SOPs on an as needed basis.
- Other duties as required in support of Catalent Pharma Solutions high performance
What you need
The Candidate
- Bachelor’s degree in a scientific field required (Chemistry or Biology preferred). Alternate degrees in a non-scientific field may be accepted with at least 2 years of relevant experience in a material testing laboratory.
- 2+ years in Quality, Laboratory, Clinical, or Chemical manufacturing role preferred.
- Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs. Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking.
Pay and benefits
Catalent didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Employee Resource Groups
Tuition reimbursement
401K match
152 hours accrued PTO
8 paid holidays
Where you'll work
Winchester, KYOn-siteOpen in Maps (opens in a new tab)
More jobs in Winchester, KY
From the posting
About Catalent
Why You Should Join Catalent
- Several Employee Resource Groups focusing on D&I
- Tuition Reimbursement – Let us help you finish your degree or earn a new one!
- Generous 401K match
- 152 hours accrued PTO + 8 paid holidays
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 4, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US79 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,250 | $73,000 | $88,250 |
Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 242 open Quality Control 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 15 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods9
- Documentation and SOPs3
- Data and digital systems1
- Collaboration and leadership1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validationNamed in the posting
- 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
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- 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 validation
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
Company hiring pulse
Catalent on Regulatory Jobs
- 35
- Open roles
- 30
- Distinct roles
- 9
- Locations
By discipline
- Quality35 100%
By level
- Associate & Specialist15 43%
- Senior & Principal14 40%
- Manager4 11%
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Quality Control Analyst at Catalent
Applications close November 24.