Quality Investigations Specialist — CAPA & Compliance

hims & hers; Gilbert (AZ); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Competitive salary and equity

Unlimited PTO

Comprehensive health benefits

ESPP

401k with employer match

Offsite team retreats

Job summary

Hims & Hers is a leading health and wellness platform focused on accessible, affordable care and outcomes-driven medicine. The Investigations Specialist role sits in our quality organization and drives root-cause analysis of deviations across 503A/503B operations.

You will partner with QA, QC, and Quality Systems to ensure timely investigations, CAPAs, and compliant documentation that supports regulatory inspections and continuous improvement.

Qualifications

• Bachelor’s degree preferred in science, quality, or engineering.
• 3+ years of quality, manufacturing, or regulated industry experience may substitute for a degree.
• Strong understanding of USP and FDA cGMP standards.

Responsibilities

• Lead and coordinate investigations of deviations, OOS, and other quality events.
• Perform root cause analyses and document findings.
• Recommend CAPAs and track their effectiveness.
• Prepare compliant reports for regulatory inspections.
• Collaborate with QA, QC, and operations during investigations.

Skills

Root cause analysis

Investigations

CAPA planning

Regulatory compliance

Quality systems

Documentation

Cross-functional collaboration

Quality assurance

Analytical skills

Education

Bachelor’s degree in science/engineering/quality

Tools

TrackWise

MasterControl

Google Workspace

Job description

Hims & Hers is a leading health and wellness platform focused on accessible, affordable care and outcomes-driven medicine. The Investigations Specialist role sits in our quality organization and drives root-cause analysis of deviations across 503A/503B operations.

You will partner with QA, QC, and Quality Systems to ensure timely investigations, CAPAs, and compliant documentation that supports regulatory inspections and continuous improvement.