Quality Specialist, Peptide API & Development

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, 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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE: We are looking for a highly organized, detail-oriented Quality Specialist to support Quality operations at a peptide-focused API manufacturing and development site. This role will help execute and maintain core GMP quality systems needed to support peptide API manufacturing, laboratory activities, and an early-phase drug product development environment designed to feed future tech transfers into 503A and 503B operations. The ideal candidate is comfortable working in a startup setting, can manage documentation and follow-through with a high level of discipline, and is eager to help build a practical, inspection-ready Quality foundation from the ground up. Core Skills & Traits - Detail-Oriented: Maintains accuracy and consistency in GMP records and documentation. - Execution-Focused: Follows through on assignments and helps drive actions to closure. - Quality Mindset: Understands the importance of compliance, traceability, and controlled execution. - Collaborative: Works effectively across Quality, Operations, Engineering, and Technical teams. - Adaptable: Comfortable supporting a growing site where systems and responsibilities are evolving. - Proactive: Identifies gaps early, asks good questions, and brings solutions-oriented thinking. YOU WILL: - Support day-to-day execution of site Quality Systems, including document control, training, deviations, CAPA, change control, and record management. - Review GMP records for completeness, accuracy, and compliance with approved procedures and Good Documentation Practices. - Assist with issuance, tracking, reconciliation, and archival of controlled documents such as SOPs, forms, logbooks, protocols, and reports. - Support batch record review activities for peptide API manufacturing and related operations, escalating issues to Quality leadership as appropriate. - Assist in tracking and coordinating deviations, investigations, CAPAs, change controls, and associated action items to closure. - Support training administration, including assignment tracking, training matrix maintenance, and follow-up on overdue training. - Participate in routine walkthroughs of manufacturing, laboratory, warehouse, and support areas to reinforce compliance and identify improvement opportunities. - Support qualification, validation, and startup documentation activities, including protocol/report routing and document completeness checks. - Assist with supplier quality, material status controls, and documentation associated with incoming materials, specifications, and quality records. - Support inspection readiness activities, including preparation of records, document retrieval, and participation in internal and external audits. - Help maintain quality metrics, logs, and trackers to support trending, management review, and continuous improvement. - Partner with Operations, Engineering, and Technical teams to ensure quality expectations are understood and implemented consistently. YOU HAVE: - Bachelor’s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related field preferred. - 2–5+ years of experience in Quality, manufacturing, laboratory, or document control roles in pharmaceutical, biotech, or other GMP-regulated environments. - Experience with peptide API, sterile operations, laboratory controls, or startup/manufacturing support environments is a plus. - Working knowledge of cGMP principles, Good Documentation Practices, and basic quality systems concepts. - Strong organizational skills with the ability to manage multiple priorities and follow through on details. - Experience using electronic quality systems, document management systems, or training systems is preferred. Working Environment - Startup environment with evolving processes and priorities. - Frequent interaction with manufacturing, laboratory, and development teams. - Regular onsite presence in GMP and support areas. - May require flexibility in working hours to support startup, validation, and operational needs. 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 accommodations@forhims.com 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 https://www.hims.com/global-candidate-privacy-statement.