Learning Specialist, Aseptic Processing

Required

• High school diploma, GED, or equivalent required; Bachelor's degree in a scientific, pharmaceutical, or related field preferred.
• Active CPhT (Certified Pharmacy Technician) certification required.
• Minimum 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding environments with hands-on aseptic processing responsibilities.
• Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff.
• Deep understanding of USP , USP , cGMP, and FDA 503A/503B regulations and their application to training and competency programs.
• Proven expertise in cleanroom protocol, contamination control, gowning, aseptic techniques, and compounding documentation practices.
• Strong facilitation and presentation skills with the ability to engage diverse audiences.
• Familiarity with regulatory compliance, training documentation, and Good Documentation Practices (GDP).
• Experience developing training SOPs, competency checklists, and aseptic simulation and media fill validation programs.
• Strong communication skills with the ability to teach complex technical topics to diverse audiences.
• Flexibility to work day or night shift as needed to support a 24/7 pharmacy operation.