Job Opportunities API

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 con