Quality Assurance-Auditor-Pest Control and Environmental Monitoring

Catalent Pharma Solutions • Winchester, KY

30d • Onsite

About The Position

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.

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.

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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED