Quality Assurance Associate
Catalent · Winchester, KY
QualityFull timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Quality Assurance Associate supporting manufacturing of solid oral dosage products at Catalent's Winchester facility. The role involves document review, real-time batch monitoring, in-process and finished product testing, and compliance verification with cGMP and regulatory requirements.
What they're looking for
- Bachelor's degree, or Associate degree with 1 year related experience, or High School Diploma/GED with 2 years related experience
- Familiarity with basic laboratory instrumentation
- Strong communication skills and English proficiency
- Knowledge of Good Laboratory Practices
- Excellent documentation and technical writing skills
- Experience with continuous improvement techniques
What you'll be doing
- Review batch records for completeness, accuracy, and compliance with critical process parameters
- Perform in-process and finished product testing including particle size, bulk density, moisture analysis, and appearance evaluations
- Conduct environmental monitoring through microbial swabbing of equipment and room surfaces
- Initiate and support deviation investigations using TrackWise system and perform root cause analysis
- Monitor manufacturing areas and enforce Good Manufacturing Practice compliance in real time
Privacy & handoff
This role links to Catalent's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.