Learning Specialist, Aseptic Processing

Define Ventures; Los Alamitos (CA); In loco; USD 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

ESPP

401k with employer matching

Descrizione del lavoro

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 role is the SME for aseptic technique, cleanroom operations, and regulatory compliance, partnering with QA, Operations, and Regulatory Compliance.

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

Competenze

• Direct experience in sterile pharmaceutical manufacturing or 503A/503B environments.
• Experience training aseptic processing personnel and evaluating competency.
• Deep knowledge of USP <797>, <800>, cGMP, and FDA 503A/503B regulations.
• Hands-on training in cleanroom operations and compounding documentation.
• Strong communication to teach complex technical topics.

Mansioni

• Develop, deliver, and improve training programs for aseptic technique and cleanroom behavior.
• Conduct hands-on training and competency assessments in simulated and live environments.
• Lead ongoing competency evaluations and retraining for regulatory compliance.
• Collaborate with Quality Assurance and Operations on root-cause training actions.
• Develop and maintain training SOPs, competency checklists, and validation docs.
• Maintain training records in FDA 503A/503B and USP guidelines.
• Stay updated on regulatory changes and best practices in training.
• Support audit readiness with complete, accessible training documentation.
• Maintain floor presence in sterile environments to monitor compliance.

Conoscenze

Sterile manufacturing experience

Training aseptic staff

USP <797>, USP <800>, cGMP knowledge

Contamination control

Gowning and aseptic techniques

Training SOPs & competency checklists

Effective communication

GDP / Good Documentation Practices

Teach complex topics

Shift flexibility (24/7)

Formazione

Bachelor's degree in scientific/pharmaceutical field

CPhT certification

Descrizione del lavoro

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:

Hims & Hers is seeking a highly experienced Learning Specialist, Aseptic Processing to lead technical training and development for aseptic processing personnel within our sterile compounding facilities. This role is the subject matter expert for aseptic technique, cleanroom operations, and sterile compounding compliance — partnering closely with Quality Assurance, Operations, and Regulatory Compliance to maintain the highest standards of product integrity and patient safety. The Learning Specialist, Aseptic Processing brings a deep technical expertise and a proven track record in hands‑on training, competency evaluation, and regulatory readiness. This role reports to the Learning team and maintains close collaboration with Quality and Compliance leadership.

You Will:

• Develop, deliver, and continuously improve comprehensive training programs for aseptic technique, cleanroom behavior, gowning, sterilization, visual inspection, and compounding procedures.

• Conduct hands‑on training and competency 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 Quality Assurance and Operations to identify training‑related root causes, and implement corrective actions through targeted education.

• Develop and maintain training SOPs, competency checklists, and aseptic simulation and media fill validation documentation.

• Maintain up‑to‑date training records and documentation in compliance with FDA 503A/503B requirements and USP guidelines.

• Stay current on regulatory changes and integrate new industry best practices and standards into training curricula.

• Support audit readiness by ensuring all training documentation is complete, accessible, and inspection‑ready.

• Maintain floor presence in sterile compounding environments to monitor compliance, identify gaps, and support continuous improvement.

You Have:

• High school diploma, GED, or equivalent required; Bachelor's degree in a scientific, pharmaceutical, or related field preferred.

• Active CPhT (Certified Pharmacy Technician) certification required.

• Minimum 5 years of direct experience in sterile pharmaceutical manufacturing, 503B outsourcing facilities, or 503A pharmacy compounding environments with hands‑on aseptic processing responsibilities.

• Minimum 3 years of experience in training and evaluating aseptic processing personnel or sterile compounding staff.

• Deep understanding of USP <797>, USP <800>, cGMP, and FDA 503A/503B regulations and their application to training and competency programs.

• Proven expertise in cleanroom protocol, contamination control, gowning, aseptic techniques, and compounding documentation practices.

• Strong facilitation and presentation skills with the ability to engage diverse audiences.

• Familiarity with regulatory compliance, training documentation, and Good Documentation Practices (GDP).

• Experience developing training SOPs, competency checklists, and aseptic simulation and media fill validation programs.

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

• Flexibility to work day or night shift as needed to support a 24/7 pharmacy operation.

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full‑time roles

• Unlimited PTO, company holidays, and quarterly mental health days

• Comprehensive health benefits including medical, dental & vision, and parental leave

• Employee Stock Purchase Program (ESPP)

• 401k benefits with employer matching contribution

• Offsite team retreats

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.