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Hims & Hers, a leading health and wellness platform and NYSE-traded public company, is seeking a QA Investigations Specialist to lead quality investigations within its 503A and 503B compounding pharmacy operations. This role is central to ensuring regulatory compliance and operational excellence in a highly regulated healthcare environment.
You will lead investigations into quality-related events including deviations, nonconformances, out-of-specification (OOS) results, and customer complaints. Your responsibilities include performing structured root cause analyses, documenting findings in compliance with USP <795>, <797>, <800>, FDA 21 CFR Parts 210 & 211, and cGMP standards. You'll collaborate closely with Quality Assurance, Quality Control, and Quality Systems teams to gather evidence, assess impact, and ensure timely closure of investigations within defined quality system timelines.
A key part of your role involves identifying and recommending Corrective and Preventive Actions (CAPAs) that are practical, risk-based, and aligned with regulatory requirements. You'll track implementation and verify effectiveness. You'll prepare clear, accurate investigation reports that support regulatory inspections and internal audits, escalating critical issues to Quality leadership as needed.
You'll work cross-functionally with production, technical teams, and quality groups, participating in site-level quality review boards and investigation committees. You'll also contribute to continuous improvement by identifying trends across investigations, recommending systemic enhancements, and supporting staff training on deviation reporting and documentation standards.
Required qualifications include a Bachelor's degree in a relevant discipline (science, quality, engineering) or 3+ years of related experience in quality, manufacturing, or regulated industries. You must have strong understanding of USP standards, FDA regulations, and cGMP practices. Pharmacy Technician or trainee licensure (or willingness to acquire) is required. You should demonstrate excellent attention to detail, strong written and verbal communication, proficiency in Google Workspace, and familiarity with quality systems software (TrackWise, MasterControl preferred). The ideal candidate is analytical, detail-oriented, a strong problem-solver, and able to manage multiple investigations under tight timelines while working independently and collaboratively.
