QA Investigations Specialist
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:
The Investigations Specialist is responsible for leading and supporting investigations into quality-related events within both 503A and 503B compounding pharmacy operations. This role collaborates with Quality Assurance (QA), Quality Control (QC), and Quality Systems to ensure thorough root cause analysis, documentation, and resolution of deviations, nonconformances, out-of-specification (OOS) results, and other quality events. The position ensures that investigations are conducted in compliance with applicable regulatory requirements, including USP <795>, <797>, <800>, FDA 503B guidance, and cGMP standards.
KEY RESPONSIBILITIES:
EVENT INVESTIGATION & ROOT CAUSE ANALYSIS
- Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS, and other quality events.
- Perform structured root cause analyses to determine true causes.
- Ensure timely initiation, progress, and closure of investigations within defined quality system ti...