Hims & Hers
Quality Assurance Investigations Specialist
New Albany, Ohio · On-site · Full-time · Posted Oct 30, 2026
- 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 (science, quality, or engineering-related field), or an equivalent combination of education and experience.
About the job
Leads investigations of quality events at a 503A compounding pharmacy, identifying root causes, coordinating corrective actions, and ensuring compliant documentation.
What you'll do
- Investigate deviations, nonconformances, complaints, out-of-specification results, and other quality events; determine root causes and document findings.
- Recommend, track, and verify corrective and preventive actions (CAPAs), including their effectiveness.
- Maintain compliant records, collaborate across quality and operational teams, and identify trends and improvements.
What they ask for
- Pharmacy Technician or trainee license, or willingness to obtain one.
- Experience with investigations, deviation management, and escalation procedures.
- Strong understanding of USP <795>, <797>, and <800>, FDA 21 CFR Parts 210 & 211, and cGMP.
- Proficiency in Google Workspace.
Nice to have
- Bachelor's degree in a relevant discipline (science, quality, or engineering-related field), or an equivalent combination of education and experience.
- GDP and GLP experience; proficiency with electronic quality systems (e.g., TrackWise, MasterControl).
Tools
USP <795>, USP <797>, USP <800>, FDA 21 CFR Parts 210 & 211, cGMP, GDP, GLP, Google Workspace
Model-written summary · the original posting is authoritative