Aseptic Processing Learning Lead - Sterile Ops & Compliance

Socket.dev

Los Alamitos (CA)

On-site

USD 90,000 - 130,000

Full time

12 days ago

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Benefits offered by this job

Competitive salary & equity
Unlimited PTO
Comprehensive health benefits
ESPP
401k with employer matching
Offsite team retreats

Job summary

Hims & Hers is seeking a Learning Specialist, Aseptic Processing to lead technical training for aseptic facilities. You will manage comprehensive programs on aseptic technique, gowning, sterilization, and compounding procedures, ensuring regulatory readiness and quality.)

The role requires hands-on training, documentation, and collaboration with Quality Assurance and Regulatory Compliance to maintain patient safety.

Qualifications

  • Strong facilitation and presentation skills for diverse audiences.
  • Experience developing training programs and SOPs for aseptic processing.
  • Deep knowledge of USP <797>, USP <800>, cGMP and FDA 503A/503B regulations.

Responsibilities

  • Develop, deliver, and improve training programs for aseptic technique and cleanroom behaviors.
  • Conduct hands-on training and competency assessments in sterile environments.
  • Maintain training records and documentation compliant with FDA requirements.
  • Support audit readiness and regulatory inspections with complete documentation.

Skills

Facilitation
Presentation skills
Training development
GxP knowledge
Regulatory compliance knowledge
Documentation practices

Education

High school diploma
Bachelor's degree in scientific/pharmaceutical field

Tools

GDP

Job description

Hims & Hers is seeking a Learning Specialist, Aseptic Processing to lead technical training for aseptic facilities. You will manage comprehensive programs on aseptic technique, gowning, sterilization, and compounding procedures, ensuring regulatory readiness and quality.)

The role requires hands-on training, documentation, and collaboration with Quality Assurance and Regulatory Compliance to maintain patient safety.

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