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 , , , 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 timelines. - Collaborate with production, QC laboratory, and QA to gather evidence and assess event impact. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) - Identify and recommend appropriate CAPAs to prevent recurrence of issues. - Ensure CAPA actions are practical, risk-based, and aligned with regulatory and company standards. - Track CAPA implementation and verify effectiveness. COMPLIANCE & DOCUMENTATION - Prepare clear, accurate, and compliant investigation reports in accordance with internal SOPs and regulatory requirements. - Maintain complete records to support regulatory inspections and internal audits. - Escalate critical issues to Quality leadership in a timely manner. CROSS-FUNCTIONAL COLLABORATION - Work closely with QA, QC, and Quality Systems to ensure consistent application of investigation procedures. - Facilitate communication between operations, technical teams, and quality groups during investigations. - Participate in site-level quality review boards or investigation review committees. CONTINUOUS IMPROVEMENT - Identify trends across investigations and recommend systemic improvements. - Support training of staff on deviation reporting, investigation practices, and documentation standards. - Contribute to enhancement of site procedures for deviation and OOS management. QUALIFICATIONS: Education & Experience - Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience. - 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree. Knowledge & Skills - Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience. - 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree. - Strong understanding of USP , , standards, FDA 21 CFR Parts 210 & 211, and cGMP. GDP and GLP practices preferred. - Excellent attention…