Aseptic Processing Training Lead - Compliance & Quality

hims-and-hers; Los Alamitos (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Unlimited PTO

Comprehensive health benefits

Employee Stock Purchase Program

401k with employer matching

Offsite team retreats

Job summary

Hims & Hers is seeking a highly experienced Learning Specialist, Aseptic Processing to lead technical training for aseptic processing personnel within our sterile compounding facilities. This SME will own training programs and ensure regulatory readiness.

You will deliver hands-on training, run competency evaluations, develop SOPs, and maintain compliance documentation per FDA 503A/503B and USP guidelines while collaborating with QA, Operations, and Regulatory.

Qualifications

• Active CPhT certification required.
• 5+ years in sterile pharma manufacturing or 503A/503B.
• 3+ years training aseptic staff.
• Deep knowledge of USP <797>/<800>, cGMP, FDA 503A/503B.
• Experience developing SOPs, checklists, media fill validation.

Responsibilities

• Develop and improve training programs for aseptic technique and cleanroom practices.
• Conduct hands-on training and competency assessments in sterile environments.
• Lead ongoing competency evaluations and retraining for compliance.
• Collaborate with QA/Operations to address training root causes.
• Create training SOPs, checklists, and validation docs.
• Maintain training records per FDA 503A/503B and USP.
• Incorporate regulatory updates into curricula.
• Support audit readiness with accessible training docs.
• Monitor floor compliance and drive continuous improvement.

Skills

Aseptic technique

Cleanroom protocol

Training & coaching

Presentation skills

Regulatory compliance

Education

Bachelor's degree in scientific/pharmaceutical field

High school diploma or GED

Job description

Hims & Hers is seeking a highly experienced Learning Specialist, Aseptic Processing to lead technical training for aseptic processing personnel within our sterile compounding facilities. This SME will own training programs and ensure regulatory readiness.

You will deliver hands-on training, run competency evaluations, develop SOPs, and maintain compliance documentation per FDA 503A/503B and USP guidelines while collaborating with QA, Operations, and Regulatory.