Katalyst HealthCares & Life Sciences | Lewisville, United States | Posted June 18, 2026
Job Description
Responsibilities:
Designs, engineers, and implements quality systems to ensure regulatory compliance and quality improvements.
This includes designing, planning, and executing validation activities for Over the Counter ( Drugs in accordance with Food & Drug Administration (FDA) regulatory guidelines.
Supports quality engineering initiatives (, conducting process capability studies and process improvement investigations), to improve quality, capacity, and efficiency while reducing costs.
Independently plan, perform and/or coordinate validation projects to ensure timely completion.
Draft and coordinate execution of validation documents for Equipment Qualification (IQOQPQ), Process Validation and Cleaning Validation/Verification.
Draft/or provide technical guidance for SOPs/Work Instructions and other master documents. Remain current with industry and regulatory agency trends.
Provide te...