Learning Lead, Aseptic Processing

About the role

This position involves leading technical training for aseptic processing staff in sterile compounding facilities. The role requires expertise in aseptic methods, cleanroom procedures, and compliance for sterile compounding. This specialist will collaborate with Quality Assurance, Operations, and Regulatory Compliance teams.

Key facts

What you'll do

• Create, deliver, and refine training programs for aseptic techniques, cleanroom conduct, gowning, sterilization, visual inspection, and compounding.
• Provide hands-on training and evaluate new and existing staff in both simulated and live sterile compounding environments.
• Manage ongoing competency assessments and retraining to ensure adherence to regulatory standards and internal procedures.
• Work with Quality Assurance and Operations to identify training-related issues and implement corrective education.
• Develop and maintain training standard operating procedures (SOPs), competency checklists, and documentation for aseptic simulations and media fills.
• Keep training records current and compliant with FDA 503A/503B and USP guidelines.
• Stay informed about regulatory changes and incorporate new industry practices into training.
• Prepare for audits by ensuring all training documentation is complete and accessible.
• Maintain a presence in sterile compounding environments to monitor compliance and identify areas for improvement.

Requirements

• High school diploma, GED, or equivalent is required.
• Active Certified Pharmacy Technician (CPhT) certification is required.
• At least 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding with aseptic processing duties.
• At least 3 years of experience training and evaluating aseptic processing or sterile compounding personnel.
• Thorough understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations as they apply to training.
• Demonstrated knowledge of cleanroom protocols, contamination control, gowning, aseptic techniques, and compounding documentation.
• Strong ability to facilitate and present information to various groups.
• Familiarity with regulatory compliance, training documentation, and Good Documentation Practices (GDP).
• Experience creating training SOPs, competency checklists, and aseptic simulation and media fill validation programs.
• Effective communication skills for teaching complex technical subjects.
• Availability to work day or night shifts to support a 24/7 pharmacy operation.

Nice to have

• Bachelor's degree in a scientific, pharmaceutical, or related field.

Skills & tools

• Aseptic technique
• Cleanroom operations
• Sterile compounding
• Gowning
• Sterilization
• Visual inspection
• USP <797>
• USP <800>
• cGMP
• FDA 503A/503B
• Good Documentation Practices (GDP)

Practical notes

This is an onsite position. Benefits include competitive salary and equity, unlimited PTO, company holidays, quarterly mental health days, comprehensive health benefits, parental leave, Employee Stock Purchase Program (ESPP), 401k with employer matching, and offsite team retreats. The company supports a diverse workforce and provides reasonable accommodations for disabilities.