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Hims & Hers, a leading telehealth and pharmacy platform (NYSE: HIMS), is seeking an experienced Learning Specialist for Aseptic Processing to lead technical training and development for personnel in its sterile compounding facilities. This role serves as the subject matter expert for aseptic technique, cleanroom operations, and sterile compounding compliance, partnering with Quality Assurance, Operations, and Regulatory Compliance to maintain product integrity and patient safety.
Key responsibilities include developing and delivering comprehensive training programs covering aseptic technique, cleanroom behavior, gowning, sterilization, visual inspection, and compounding procedures. You will conduct hands-on training and competency assessments for new hires and experienced staff in both simulated and live sterile compounding environments. The role involves leading ongoing competency evaluations and retraining initiatives to ensure compliance with regulatory standards and internal SOPs.
You will collaborate with Quality Assurance and Operations to identify training-related root causes and implement corrective actions through targeted education. Responsibilities include developing and maintaining training SOPs, competency checklists, and aseptic simulation and media fill validation documentation. You must maintain up-to-date training records in compliance with FDA 503A/503B requirements and USP guidelines, stay current on regulatory changes, and integrate industry best practices into training curricula.
The role supports audit readiness by ensuring all training documentation is complete and inspection-ready, and requires maintaining floor presence in sterile compounding environments to monitor compliance and identify gaps. You will support a 24/7 pharmacy operation with flexibility to work day or night shifts as needed.
Required qualifications: Active CPhT (Certified Pharmacy Technician) certification, minimum 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding with hands-on aseptic processing, and minimum 3 years of experience training and evaluating aseptic processing personnel. Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations is essential. Bachelor's degree in a scientific, pharmaceutical, or related field is preferred.
