QA Analytical Auditor

Catalent; Winchester (KY); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive PTO (8 holidays)

Medical, dental, vision benefits from

Job summary

Catalent’s Winchester, KY site seeks a QA Analytical Auditor to support release of QC lab materials and ensure GMP/analytical compliance. You will review data, participate in audits, support investigations, and help train Analysts in a fast-paced on-site environment.

Shift: Mon-Fri 8 AM–5 PM; 100% on-site in Winchester, KY. Requires a scientific degree and relevant lab experience with Empower software proficiency.

Qualifications

• Bachelor’s degree in a scientific field with 2 years of related experience required.
• Alternate degrees in a non-scientific field may be accepted with at least 3 years of relevant experience in a material testing laboratory.
• Proficient in English verbal and written communication skills.
• Ability to work effectively under pressure to meet deadlines.
• Ability to multi-task with high efficiency.
• Ability to coordinate and prioritize to support manufacturing and quality agreements.
• Strong knowledge in Empower software.
• Advanced knowledge and demonstrated performance in lab safety processes and ability to work safely with chemicals of varying potency.
• General computer literacy including Microsoft Word and Excel.
• Accurate testing on the first attempt under production pressure.
• Proven ability to support multiple projects simultaneously while meeting deadlines and producing high-quality work with minimal supervision.
• Proven track record of obtaining high-quality results with minimal errors and corrections.
• Specific vision requirements include reading written documents and frequent use of computer monitor and chemical testing materials.

Responsibilities

• Support release of raw materials, in-process, and finished products by reviewing GMP documents for compliance and technical accuracy.
• Read and understand test methods from multiple compendia, internal Catalent methods, or customer/supplier methods.
• Participate in customer and agency audits as necessary.
• Assist in training Quality Control Analysts.
• Assist in laboratory investigations.
• Draft or review standard operating procedures as needed.
• Draft or review corrective and preventive actions and audit responses as needed.
• Perform other duties as required in support of Catalent Pharma Solutions high performance.

Skills

English communication

Multi-tasking

Time management

Lab safety

MS Word

MS Excel

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Tools

Empower software

Job description

About Site

Catalent’s Winchester, KY site is the company’s flagship U.S. manufacturing location for large‑scale oral solid dose forms, operating from a 180,000‑square‑foot facility with fully integrated development and analytical services. The site specializes in complex and controlled‑release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent’s oral dose network.

Position Summary

We have an opportunity for a QA Analytical Auditor to join our team. This role supports the release of all materials from the quality control lab and ensures compliance with technical and analytical requirements. You will manage your time effectively, work with minimal direction, and handle a wide range of high-visibility tasks. The position involves reviewing data for GMP compliance, supporting investigations, and participating in audits to maintain quality standards.

Shift: Monday-Friday 8 AM - 5 PM

Location: Winchester, KY

100% Onsite

The Role

• Support release of raw materials, in-process, and finished products by reviewing GMP documents for compliance and technical accuracy
• Read and understand test methods from multiple compendia, internal Catalent methods, or customer/supplier methods
• Participate in customer and agency audits as necessary
• Assist in training Quality Control Analysts
• Assist in laboratory investigations
• Draft or review standard operating procedures as needed
• Draft or review corrective and preventive actions and audit responses as needed
• Perform other duties as required in support of Catalent Pharma Solutions high performance

The Candidate

Minimum Requirements

• Bachelor’s degree in a scientific field with 2 years of related experience required
• Alternate degrees in a non-scientific field may be accepted with at least 3 years of relevant experience in a material testing laboratory
• Proficient in English verbal and written communication skills
• Ability to work effectively under pressure to meet deadlines
• Ability to multi-task with high efficiency
• Ability to coordinate and prioritize to support manufacturing and quality agreements
• Ability to work well under pressure and maintain efficiency individually and in a team
• Strong knowledge in Empower software
• Advanced knowledge and demonstrated performance in lab safety processes and ability to work safely with chemicals of varying potency
• General computer literacy including Microsoft Word and Excel
• Accurate testing on the first attempt under production pressure
• Proven ability to support multiple projects simultaneously while meeting deadlines and producing high-quality work with minimal supervision
• Proven track record of obtaining high-quality results with minimal errors and corrections
• Individual may be required to sit and stand for an extended period of time
• Specific vision requirements include reading written documents and frequent use of computer monitor and chemical testing materials

Preferred Skills & Background

• Bachelor’s degree in Chemistry or Biology
• 3+ years in Quality, Laboratory, Clinical, or Chemical manufacturing role (including internships or co-op experience) auditing testing data and results
• Experience in the pharmaceutical industry preferred
• Previous analytical testing experience is preferred

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continual improvement and innovation
• Competitive Paid Time Off plus 8 paid holidays
• Medical, dental, and vision benefits effective day one of employment
• Tuition Reimbursement to help you finish your degree or earn a new one
• Site-based Employee Engagement activities such as NCAA Basketball Brackets, Golf Scrambles, and Annual Onsite Pet Adoption Events
• Employee Resource Groups focusing on Diversity and Inclusion
• Environmentally friendly initiatives including Adopt-a-Highway Clean-up
• Defined career path with annual performance reviews and growth opportunities
• WellHub program promoting physical and mental wellness
• Perkspot discounts from over 900 merchants in various categories

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.

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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.