Compensation: $38 – $43 per hour

About the Role: The Learning Specialist, Aseptic Processing brings a deep technical expertise and a proven track record in hands-on training, competency evaluation, and regulatory readiness. This role reports to the Learning team and maintains close collaboration with Quality and Compliance leadership.

Responsibilities:

• Develop, deliver, and continuously improve comprehensive training programs for aseptic technique, cleanroom behavior, gowning, sterilization, visual inspection, and compounding procedures.
• Conduct hands-on training and competency assessments for new hires and experienced staff in both simulated and live sterile compounding environments.
• Lead ongoing competency evaluations and retraining initiatives to ensure continuous compliance with regulatory standards and internal SOPs.
• Collaborate with Quality Assurance and Operations to identify training-related root causes, and implement corrective actions through targeted education.
• Develop and maintain training SOPs, competency checklists, and aseptic simulation and media fill validation documentation.
• Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements and USP guidelines.
• Stay current on regulatory changes and integrate new industry best practices and standards into training curricula.
• Support audit readiness by ensuring all training documentation is complete, accessible, and inspection-ready.
• Maintain floor presence in sterile compounding environments to monitor compliance, identify gaps, and support continuous improvement.

Requirements:

• 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 <797>, USP <800>, 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.

Benefits:

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

XML job scraping automation by YubHub