Quality Assurance Associate

Quality Assurance Associate 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 Quality Assurance Associate to join our team. In this role, you will provide quality support for the manufacturing of solid oral dosage products. You will review and approve documents, monitor manufacturing activities in real time, and test in-process and finished product samples. This position ensures compliance with cGMP, CFR, and Catalent SOP requirements while supporting continuous improvement initiatives.

Shift: F Shift (Friday - Sunday 6 PM - 6 AM; every other Monday)

Location:

Winchester, KY 100% Onsite

The Role Recommend Standard Operating Procedure and batch record changes as needed.

Review proposed Standard Operating Procedure revisions and provide feedback to management.

Conduct real-time audits of batch records for completeness, documentation accuracy, calculation verification, and compliance with critical process parameters.

Perform room and equipment clearances following production cleaning activities.

Perform environmental monitoring through microbial swabbing of equipment and room surfaces.

Maintain working knowledge of all applicable Catalent Standard Operating Procedures, policies, current Good Manufacturing Practices, and Code of Federal Regulations requirements.

Perform routine testing of in-process and finished product samples, including particle size analysis, bulk density testing, moisture analysis, appearance evaluations, and Acceptable Quality Level testing.

Monitor manufacturing areas to ensure compliance with Standard Operating Procedures, current Good Manufacturing Practices, batch records, and safety requirements.

Identify and resolve routine errors and prevent deviations in real time.

Collaborate cross-functionally to assess potential deviations and determine investigation requirements.

Initiate deviation reports in Track Wise with sufficient documentation for investigation.

Manage quality status of work-in-process and finished goods in both physical inventory and JD Edwards inventory systems.

Support investigations by gathering data and assisting with root cause analysis.

Enforce Good Manufacturing Practice compliance.

Promote teamwork and effective communication.

Provide training and coaching to manufacturing personnel as needed.

Support site process improvements, training initiatives, efficiency projects, and Corrective and Preventive Action implementations.

Investigate customer complaints.

Perform other duties as assigned.

The Candidate

Minimum Requirements Bachelor's degree; OR Associate degree with 1 year of related experience; OR High School Diploma/GED with 2 years of related experience.

Familiarity with basic laboratory instrumentation.

Safe work habits.

Basic math and computer skills.

Strong communication skills and English proficiency.

Ability to follow written and verbal instructions.

Ability to work with limited supervision on routine tasks.

Excellent documentation and handwriting skills.

Technical writing skills.

Knowledge of Good Laboratory Practices.

Experience with continuous improvement techniques.

Ability to work effectively under pressure…