Winchester, Kentucky, United States
Onsite
Quality Assurance Auditor - Pest Control and Environmental Monitoring
About Site
Catalent’s Winchester facility is a modern manufacturing site dedicated to producing high-quality oral solid dose products for the pharmaceutical industry. The site operates with advanced technologies and a strong focus on quality, safety, and efficiency, supporting both commercial and clinical supply needs. Employees here work in a collaborative environment that values innovation and continuous improvement, contributing to the development and delivery of life-changing medicines. This location offers a dynamic setting where professionals can grow their expertise while being part of a team committed to excellence in every aspect of production.
Position Summary
We have an opportunity for a QA Auditor - Pest Control & EM to join our team. This role supports documentation review for the Quality Assurance department and requires strong knowledge of technical and process requirements as well as quality systems. You will manage your time effectively and work with minimal direction while handling a broad range of high-visibility tasks. The position involves supporting quality investigations, audits, and process improvements to ensure compliance and operational excellence.
Shift: Monday-Friday 8 AM -5 PM
Location: Winchester, KY
100% Onsite
The Role
Manage the pest control program
Manage Environmental Monitoring systems, including critical alarms
Review master data for work in progress and finished goods
Audit GMP documents such as batch records, logbooks, and forms for completeness, accuracy, and compliance with critical process parameters
Work cross-functionally to assess potential deviations and determine if investigations are required
Assist in quality investigations and draft or review corrective and preventive actions (CAPAs) and audit responses
Partner with internal teams to ensure timely audits of documentation related to manufacturing or material release
Participate in customer and agency audits as needed
Perform audits of quality processes as necessary
Draft or review standard operating procedures and recommend changes to SOPs and batch records as needed
Support site process improvements, including training, efficiency projects, and CAPA implementation
Perform other duties as required to support high performance at Catalent Pharma Solutions
The Candidate
Minimum Requirements
High School Diploma with a minimum of 4 years of relevant experience in a regulated GMP manufacturing environment
Individual may be required to sit, stand, and walk for extended periods
Specific vision requirements include reading written documents and frequent use of a computer monitor
Preferred Skills & Background
Bachelor’s Degree in a related science or technical field preferred
Additional qualifications such as Lean Six Sigma, ASQ certification, or other professional certifications preferred
Process improvement skills preferred
Why You Should Join Catalent
Positive and fast-paced working environment focused on continuous improvement and innovation
Competitive Paid Time Off plus 8 paid holidays
Medical, dental, and vision benefits effective from day one
Tuition reimbursement to support your educational goals
Engaging site-based activities such as NCAA Basketball Brackets, Golf Scrambles, and Onsite Pet Adoption Events
Employee Resource Groups promoting diversity and inclusion
Community engagement initiatives including Adopt-a-Highway clean-up
Defined career path with annual performance reviews and growth opportunities
WellHub program for physical and mental wellness
Exclusive discounts through Perkspot from over 900 merchants
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.
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.
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