Quality Assurance-Auditor-Pest Control and Environmental Monitoring

Quality Assurance Auditor – Pest Control & EM

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.

Location:

Winchester, KY. Shift: Monday‑Friday 8 AM – 5 PM. 100% onsite.

This role supports documentation review for the Quality Assurance department and requires strong knowledge of technical and process requirements as well as quality systems. The auditor will manage the pest control program, environmental monitoring systems, review master data for work in progress and finished goods, audit GMP documents, work cross‑functionally to assess deviations, assist in quality investigations and draft or review corrective and preventive actions (CAPAs) and audit responses, partner with internal teams to ensure timely audits, participate in customer and agency audits as needed, perform audits of quality processes, draft or review SOPs, support site process improvements, and perform other duties as required to support high performance at Catalent Pharma Solutions.

• 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.

• High School Diploma with a minimum of 4 years of relevant experience in a regulated GMP manufacturing environment.
• 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.

• Bachelor’s Degree in a related science or technical field.
• Qualifications such as Lean Six Sigma, ASQ certification, or other professional certifications.
• Process improvement skills.

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, please contact Disabili