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hims & hers · 2 weeks ago

Pharmaceutical Aseptic Processing Trainer (Nights)

New Albany, Ohio

Full-time

Onsite

Senior Level

5+ years exp

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. They are seeking a highly experienced Pharmaceutical Aseptic Processing Trainer to lead training and development programs for aseptic processing personnel within their sterile compounding facility.

Health CareLifestyleMen'sWellnessWomen's

Responsibilities

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

Qualification

Aseptic processingSterile pharmaceutical manufacturingTrainingEvaluationCGMP complianceUSP <797>/<800> knowledgeQuality assurance techniquesCommunication skillsMentorshipCollaboration

Required

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

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 techniques

Demonstrated experience applying quality assurance techniques such as root cause analysis, deviation/investigation management, CAPA processes, and documentation best practices

Experience in developing training SOPs, competency checklists, and aseptic simulation media fill validation

Strong communication skills with the ability to teach complex topics to diverse audiences

Ability to work primarily night shift hours, with flexibility to cover day shift hours as needed to support our 24/7 pharmacy operation

This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs

This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR)

Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs

Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs