Pharmaceutical Aseptic Processing Trainer

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.About the Role:We are seeking a highly experienced and knowledgeable Pharmaceutical Aseptic Processing Trainer to lead training and development programs for aseptic processing personnel within our sterile compounding facility. This role plays a critical part in ensuring that compounding staff are well-equipped with the technical knowledge and practical skills required to maintain compliance with cGMP, USP <797>/<800>, and FDA 503A/503B regulatory requirements.The ideal candidate will bring deep subject-matter expertise in sterile pharmaceutical manufacturing and aseptic processing, with a proven track record in hands-on training and evaluation of compounding operators. This position will collaborate closely with Quality Assurance, Operations, Learning, and Compliance teams to maintain the highest standards in product integrity and patient safety.You Will:Develop, deliver, and continuously improve comprehensive training programs for aseptic technique, cleanroom behavior, environmental monitoring practices, gowning, sterilization, visual inspection and compounding procedures.Conduct hands-on training and 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 QA and Operations to investigate deviations, identify training-related root causes, and implement corrective actions through targeted education.Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements, USP guidelines, and cGMP practices.Stay informed on regulatory changes and integrate new industry best practices into training curricula.Provide mentorship and technical guidance to aseptic operators and pharmacy technicians to elevate team performance and product quality.Ability to work primarily night shift hours, with flexibility to cover day shift hours as needed to support our 24/7 pharmacy operation.You Have:Minimum 5 years of direct experience working in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding environments, with hands-on aseptic processing responsibilities in manual and semi-automated filling techniques.Current registration as a Certified Pharmacy Technician in the State of Ohio and National Certification (CPhT).Bachelor’s degree required, preferably in Pharmaceutical Sciences, Microbiology, Biology, Chemistry, Quality Assurance, or a closely related field.Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff. Experience delivering hands-on training in both individualized (1:1) and group/classroom environments preferred.Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations.Proven expertise in cleanroom protocol, contamination control, gowning, and aseptic techniquesDemonstrated experience applying quality assurance techniques such as root cause analysis, deviation/investigation management, CAPA processes, ... (truncated, view full listing at source)