Pharmaceutical Aseptic Processing Trainer
Pharmaceutical Aseptic Processing Trainer
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Job Description
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 were 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 and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: We are seeking a highly experienced and knowledgeable Pharmaceutical Aseptic Processing Trainer to lead training and development programs for aseptic processing personnel within our sterile compounding facility. This role plays a critical part in ensuring that compounding staff are well-equipped with the technical knowledge and practical skills required to maintain compliance with cGMP USP <797>/<800> and FDA 503A/503B regulatory requirements. The ideal candidate will bring deep subject-matter expertise in sterile pharmaceutical manufacturing and aseptic processing with a proven track record in hands-on training and evaluation of compounding operators. This position will collaborate closely with Quality Assurance Operations Learning and Compliance teams to maintain the highest standards in product integrity and patient safety. 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 day shift or night shift hours as needed to support our 24/7 pharmacy operation. 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. 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. Proven expertise in cleanroom protocol contamination control gowning aseptic techniques and compounding documentation 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. Background in auditing or regulatory inspections (e.g. FDA BOP PCAB) is a plus. Competitive salary & comprehensive health benefits including medical dental & vision Conditions of Employment: 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. These items would include gloves respiratory protection gown and other items as required. 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. We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre 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 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 ourGlobal Candidate Privacy Statement.You Will:
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Employment Type
Full-Time
