Pharma Quality Assurance Investigator & CAPA Lead

Hims & Hers; Gilbert (AZ); On-site; USD 65,000 - 110,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO & holidays

Health benefits

ESPP

Employee discounts on products

401k with matching

Offsite team retreats

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, ensure regulatory compliance (USP <795>, <797>, <800>), and drive CAPA actions with cross-functional teams.

You will report to the Quality Assurance Manager and collaborate with QC, QA, and production to maintain rigorous documentation and continuous improvement. M-F 8-5.

Qualifications

• Bachelor’s degree preferred in science, quality, or engineering.
• 3+ years of related experience in quality, manufacturing, or regulated industry may substitute for a degree.
• Pharmacy Technician or trainee license, or willingness to obtain one.

Responsibilities

• Investigate customer complaints and quality events with pharmacists to assess product quality events.
• Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS results, and other quality events.
• Perform structured root cause analyses to determine true causes.
• Ensure timely initiation, progress, and closure of investigations within defined quality system timelines.
• Collaborate with production, QC laboratory, and QA to gather evidence and assess event impact.

Skills

Quality Systems

Root Cause Analysis

Documentation

Regulatory Knowledge

CAPA Processes

GMP/Regulatory understanding

Education

Bachelor's degree

3+ years experience in quality/manufacturing

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, ensure regulatory compliance (USP <795>, <797>, <800>), and drive CAPA actions with cross-functional teams.

You will report to the Quality Assurance Manager and collaborate with QC, QA, and production to maintain rigorous documentation and continuous improvement. M-F 8-5.