QA Analytical Auditor

QA Analytical Auditor About SiteCatalent’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 SummaryWe 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 PMLocation: Winchester, KY100% OnsiteThe RoleSupport release of raw materials, in-process, and finished products by reviewing GMP documents for compliance and technical accuracyRead and understand test methods from multiple compendia, internal Catalent methods, or customer/supplier methodsParticipate in customer and agency audits as necessaryAssist in training Quality Control AnalystsAssist in laboratory investigationsDraft or review standard operating procedures as neededDraft or review corrective and preventive actions and audit responses as neededPerform other duties as required in support of Catalent Pharma Solutions high performanceThe CandidateMinimum RequirementsBachelor’s degree in a scientific field with 2 years of related experience requiredAlternate degrees in a non-scientific field may be accepted with at least 3 years of relevant experience in a material testing laboratoryProficient in English verbal and written communication skillsAbility to work effectively under pressure to meet deadlinesAbility to multi-task with high efficiencyAbility to coordinate and prioritize to support manufacturing and quality agreementsAbility to work well under pressure and maintain efficiency individually and in a teamStrong knowledge in Empower softwareAdvanced knowledge and demonstrated performance in lab safety processes and ability to work safely with chemicals of varying potencyGeneral computer literacy including Microsoft Word and ExcelAccurate testing on the first attempt under production pressureProven ability to support multiple projects simultaneously while meeting deadlines and producing high-quality work with minimal supervisionProven track record of obtaining high-quality results with minimal errors and correctionsIndividual may be required to sit and stand for an extended period of timeSpecific vision requirements include reading written documents and frequent use of computer monitor and chemical testing materialsPreferred Skills & BackgroundBachelor’s degree in Chemistry or Biology3+ years in Quality, Laboratory, Clinical, or Chemical manufacturing role (including internships or co-op experience) auditing testing data and resultsExperience in the pharmaceutical industry preferredPrevious analytical testing experience is preferredWhy You Should Join CatalentPositive and fast-paced working environment focusing on continual improvement and innovationCompetitive Paid Time Off plus 8 paid holidaysMedical, dental, and vision benefits effective day one of employmentTuition Reimbursement to help you finish your degree or earn a new oneSite-based Employee Engagement activities such as NCAA Basketball Brackets, Golf Scrambles, and Annual Onsite Pet Adoption EventsEmployee Resource Groups focusing on Diversity and InclusionEnvironmentally friendly initiatives including Adopt-a-Highway Clean-upDefined career path with annual performance reviews and growth opportunitiesWellHub program promoting physical and mental wellnessPerkspot discounts from over 900 merchants in various categoriesCatalent 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 View email address on click.appcast.io. 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.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 View email address on click.appcast.io 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.SummaryLocation: Winchester, KYType: Full time