Senior Aseptic Training Specialist

Hims, Inc.; Los Alamitos (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Unlimited PTO

Health benefits

ESPP

401k with employer match

Offsite team retreats

Job summary

Hims & Hers is seeking a highly experienced Learning Specialist, Aseptic Processing to lead technical training for aseptic processing personnel in sterile compounding facilities. You will serve as SME for aseptic technique, cleanroom operations, and regulatory readiness, partnering with Quality Assurance and Compliance.

You will develop and deliver training programs, conduct hands-on assessments, and maintain documentation to ensure FDA USP and 503A/503B compliance across sites.

Qualifications

• Requires high school diploma, GED, or equivalent.
• Bachelor’s degree in a scientific/pharmaceutical field preferred.
• Active CPhT certification required.
• Minimum 5 years in sterile pharmaceutical manufacturing or 503A/503B environments.
• Minimum 3 years in training/ evaluating aseptic staff.
• Deep understanding of USP <797>, <800>, cGMP, FDA 503A/503B regs.
• Experience developing training SOPs and competency checklists.
• Strong communication & facilitation skills.
• Willingness to work day or night shifts for 24/7 operations.

Responsibilities

• Develop and deliver comprehensive training programs for aseptic technique and cleanroom behavior.
• Conduct hands-on training and competency assessments in sterile environments.
• Lead ongoing competency evaluations and retraining for regulatory compliance.
• Collaborate with QA and Operations to identify training root causes and corrective actions.
• Develop training SOPs, competency checklists, and validation documentation.
• Maintain training records compliant with FDA and USP guidelines.
• Stay current on regulatory changes and update curricula accordingly.
• Support audit readiness with complete, accessible training documentation.
• Maintain floor presence to monitor compliance and drive improvements.

Skills

Training delivery

Facilitation

Regulatory knowledge

Clinical/pharma ops

Education

Bachelor's degree in science or related field

CPhT certification

Tools

GDP & documentation practices

Job description

Hims & Hers is seeking a highly experienced Learning Specialist, Aseptic Processing to lead technical training for aseptic processing personnel in sterile compounding facilities. You will serve as SME for aseptic technique, cleanroom operations, and regulatory readiness, partnering with Quality Assurance and Compliance.

You will develop and deliver training programs, conduct hands-on assessments, and maintain documentation to ensure FDA USP and 503A/503B compliance across sites.