A global leader in animal health with a multi-million-dollar global footprint is seeking a Senior Quality Associate – Sterility Assurance to coach QA manufacturing operations on the floor. The person will oversee and contribute to Sterility Assurance/Contamination Control Strategy deliverables.

Responsibilities

•  You will serve as the primary technical expert in contamination control, aseptic processing, and sterilization.
•  Coach and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance, including aseptic processing, media fills, and sterilization cycles.
• Identify and troubleshoot issues related to sterility assurance.
• Responsible for operational excellence/continuous improvement of the site.

Qualifications & Requirements 

• 3+ years of experience in sterile processing, and contamination control.
• 5+ years of QA experience in GMP environment
• Experience coaching on floor as related to QA for manufacturing operations
• Hands on environmental monitoring, medial fills and aseptic training/gowning experience.