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Winchester, Virginia, United States
Onsite
QA Analytical Auditor
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.
Visit Catalent Careers to explore career opportunities.
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 DisabilityAccommodations@catalent.com. 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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