Quality Control Analyst

Regulatory Jobs; Winchester (KY); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Tuition Reimbursement

401K match

PTO + holidays

Job summary

Catalent in Winchester, Kentucky seeks a Quality Control Analyst to perform day-to-day analytical work in a GMP laboratory, generating data and preparing reports. The role involves testing such as Dissolution, Titration, HPLC, GC, and FTIR under regulatory guidelines.

The candidate will hold a bachelor’s degree in a scientific field and 2+ years of lab/quality experience, with an 11 PM–7:30 AM shift. This on-site position requires safe lab practices and accurate record keeping.

Qualifications

• Bachelor’s degree in a scientific field is required.
• 2+ years in Quality, Laboratory, Clinical, or Chemical manufacturing is preferred.
• Ability to lift and move items up to 50 lbs; operate safely in a dynamic lab environment.

Responsibilities

• Perform analytical testing per USP/NF/EP/JP/FCC or customer guidelines.
• Maintain accurate written records of all analyses.
• Interpret and communicate analytical results and issues effectively.

Skills

Analytical lab skills

Record keeping

Data interpretation

Communication

Education

Bachelor’s degree in a scientific field

2+ years of relevant experience in material testing laboratory

Tools

HPLC

GC

FTIR

Job description

Quality Control Analyst

Position Summary

• 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.

The Role

• Performefficient/reliable/highqualityanalyticaltestinginaccordancewithUSP/NF/EP/JP/FCC/etc.orcustomer 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

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. Operatingsafelyinadynamicenvironmentwhichincludesmobileandfixedequipmentandchanging conditions while completing job tasks that range from simple to complex and/or multi-tasking.

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.

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 [e-mail]. 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.

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.