QA Investigations Lead – CAPA & Root Cause (Pharma)

Hims & Hers; Mesa (AZ); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Unlimited PTO

Health benefits

401k with employer match

Employee Stock Purchase Program (ESPP)

Job summary

Hims & Hers is seeking an experienced Quality Assurance Investigations Specialist for our Gilbert, AZ compounding pharmacy. You will lead investigations into quality events, perform root‑cause analyses, and ensure compliance with USP standards and FDA regulations.

You’ll collaborate with QA, QC, and production to drive CAPAs and maintain thorough documentation for regulatory inspections. Monitors will be in a 8–5pm M-F schedule on-site.

Qualifications

• Bachelor's degree preferred in science, quality or engineering or equivalent.
• 3+ years in quality, manufacturing, or regulated industry; degree may be substituted.
• Pharmacy Technician license or willingness to obtain one.
• Strong understanding of USP <795>, <797>, <800>, FDA 21 CFR Parts 210 & 211, and cGMP.
• Experience with investigations, deviation management, and escalation procedures.
• Excellent attention to detail, documentation, and organizational skills.
• Strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Investigate customer complaints and quality events with pharmacists.
• Lead, document, and coordinate investigations of deviations, nonconformances, complaints, and OOS results.
• Perform structured root cause analyses to determine true causes.
• Ensure timely initiation and closure of investigations within quality system timelines.
• Collaborate with production, QC lab, and QA to gather evidence and assess impact.
• Prepare clear, compliant investigation reports for regulatory inspections.
• Support CAPA actions and track effectiveness.

Skills

Investigations

Root cause analysis

Cross-functional collaboration

Documentation practices

Time management

Communication skills

Problem solving

Education

Bachelor's degree in science/quality/engineering

3+ years quality/manufacturing/regulatory experience

Pharmacy Technician license or trainee

Tools

TrackWise

MasterControl

Google Workspace

Job description

Hims & Hers is seeking an experienced Quality Assurance Investigations Specialist for our Gilbert, AZ compounding pharmacy. You will lead investigations into quality events, perform root‑cause analyses, and ensure compliance with USP standards and FDA regulations.

You’ll collaborate with QA, QC, and production to drive CAPAs and maintain thorough documentation for regulatory inspections. Monitors will be in a 8–5pm M-F schedule on-site.