Hiring: Quality Assurance Associate Company: Catalent Location: Winchester, KY Job Posted Time: 2026-09-10 11:32:21 Employment Type: On-site Target Skills & Keywords : Quality Assurance, Root Cause Analysis, Six Sigma About the job Experience: •Bachelor's degree; OR Associate degree with 1 year of related experience; OR High School Diploma/GED with 2 years of related experience. •1 year of related experience; OR High School Diploma/GED with 2 years of related experience. Required Skills: •Shift: E Shift (Friday - Sunday 6 AM - 6 PM; every other Monday) •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. Qualifications: •Operational familiarity with basic laboratory instrumentation. •Basic math and computer skills. •Strong communication skills and English proficiency. •Demonstrated capacity to follow written and verbal instructions. •Demonstrated capacity to work with limited supervision on routine tasks. •Excellent documentation and handwriting skills. •Knowledge of Good Laboratory Practices. •Demonstrated capacity to work effectively under pressure and meet deadlines. Prolonged sitting, standing, and walking. Frequent computer use and document review. •American Society for Quality certification. Compensation: •Competitive Paid Time Off plus 8 paid holidays Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!