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Hims & Hers, a leading health and wellness platform and NYSE-traded public company, is seeking a Quality Assurance Investigations Specialist to join the Quality Unit at its 503A compounding pharmacy in Gilbert, Arizona. Reporting to the Quality Assurance Manager, you will lead and support investigations into quality-related events within compounding pharmacy operations, partnering closely with Quality Control (QC) and Quality Systems teams.
Key responsibilities include investigating customer complaints and quality-related events (deviations, nonconformances, complaints, out-of-specification results) in collaboration with pharmacists; performing structured root cause analyses to determine true causes; ensuring timely initiation, progress, and closure of investigations within defined quality system timelines; and collaborating with production, QC laboratory, and QA teams to gather evidence and assess event impact.
You will identify and recommend appropriate Corrective and Preventive Actions (CAPAs) to prevent recurrence of issues, ensure CAPA actions are practical and risk-based, and track implementation and effectiveness. You will prepare clear, accurate, and compliant investigation reports in accordance with internal SOPs and regulatory requirements; maintain complete records to support regulatory inspections and audits; and escalate critical issues to Quality leadership timely.
Cross-functional collaboration is essential: you will work closely with QA, QC, and Quality Systems teams; facilitate communication between operations, technical teams, and quality groups during investigations; and participate in site-level quality review boards and investigation review committees.
You will also identify trends across investigations and recommend systemic improvements, support staff training on deviation reporting and investigation practices, and contribute to enhancement of site procedures for deviation and out-of-specification management.
The role is Monday–Friday, 8 AM–5 PM. You will work with hazardous drugs and must wear appropriate personal protective equipment (gloves, respiratory protection, gown, and other items as required). Medical approval to wear respiratory protection is required. Physical exertion is required, including walking up to 50% of the time, standing up to 100%, squatting and bending up to 20%, and lifting up to 50 lbs. You must confirm understanding of potential risks (teratogenicity, carcinogenicity, reproductive effects) of handling hazardous drugs.
QUALIFICATIONS:
Education & Experience:
- Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field), or equivalent combination of education and experience
- 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree
- Pharmacy Technician or trainee license, or willingness to obtain one
Knowledge & Skills:
- Strong understanding of USP <795>, <797>, and <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP; GDP and GLP experience preferred
- Experience with investigations, deviation management, and escalation procedures
- Excellent attention to detail, documentation practices, and organizational skills
- Excellent written and verbal communication skills, including technical writing
- Strong collaboration skills across multidisciplinary teams
- Ability to manage multiple investigations under tight timelines
- Proficiency in Google Workspace; proficiency with electronic quality systems (e.g., TrackWise, MasterControl) preferred
Key Competencies:
- Analytical and detail-oriented mindset
- Strong problem-solving and decision-making abilities
- Clear and professional communication
- High sense of accountability and ownership
- Ability to work independently and within cross-functional teams
