Hims & Hers
Quality Assurance Investigations Specialist
Mesa, Arizona +1 · On-site · Full-time · Posted Oct 19, 2026
- Location
- Mesa, Arizona
Gilbert, Arizona - Experience
- 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
- Education
- Bachelor's degree preferred in a relevant discipline, or an equivalent combination of education and experience.
About the job
Investigates quality events at a 503A compounding pharmacy, determines root causes, coordinates corrective actions, and maintains regulatory-compliant documentation.
What you'll do
- Lead investigations of complaints, deviations, nonconformances, out-of-specification results, and other quality events; perform root cause analysis.
- Recommend, track, and verify corrective and preventive actions (CAPAs).
- Prepare compliant investigation records, collaborate across quality and operations teams, and identify trends for improvement.
What they ask for
- Experience with investigations, deviation management, and escalation procedures.
- Strong understanding of USP <795>, <797>, and <800>, FDA 21 CFR Parts 210 & 211, and cGMP.
- Pharmacy Technician or trainee license, or willingness to obtain one.
- Proficiency in Google Workspace; strong documentation and communication skills.
Nice to have
- Bachelor's degree in a relevant discipline (science, quality, or engineering-related field).
- GDP and GLP experience; electronic quality systems such as TrackWise or MasterControl.
Tools
USP <795>, USP <797>, USP <800>, FDA 21 CFR Parts 210 & 211, cGMP, Google Workspace, TrackWise, MasterControl
Model-written summary · the original posting is authoritative