Quality Specialist, Peptide API & Development
Job Location:
Menlo Park, CA - USA
Yearly Salary:
Posted on:
Vacancies:
Job Summary
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 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. 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. Bachelors degree in Chemistry Biology Biochemistry Pharmaceutical Sciences or related field preferred. 25 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. 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 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. Required Experience: ICYou Will:
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About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
