Quality Assurance Associate

Catalent · Winchester, KY

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Role summary

Quality Assurance Associate position supporting manufacturing of solid oral dosage products at Catalent's Winchester, Kentucky facility. The role involves reviewing documentation, monitoring production activities, testing samples, and ensuring compliance 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 handwriting skills
Technical writing capability
Experience with continuous improvement techniques

What you'll be doing

Review and approve manufacturing documents; recommend Standard Operating Procedure and batch record changes
Conduct real-time audits of batch records for accuracy, completeness, and regulatory compliance
Perform environmental monitoring and equipment clearances following production cleaning activities
Test in-process and finished product samples including particle size, density, moisture, and appearance analysis
Initiate deviation reports and support root cause analysis investigations

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