Description
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health.
We are seeking an experienced Quality Assurance Investigations Specialist to join the Quality Unit at our compounding pharmacy in Gilbert, Arizona. In this role, you will lead and support investigations into quality-related events within our 503A compounding pharmacy operations.
Key Responsibilities:
- Investigate customer complaints and quality-related events, working closely 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, the QC laboratory, and QA to gather evidence and assess event impact
- Identify and recommend appropriate Corrective and Preventive Actions (CAPAs) to prevent recurrence of issues
- Prepare clear, accurate, and compliant investigation reports in accordance with internal SOPs and regulatory requirements
- Maintain complete records to support regulatory inspections and internal audits
- Escalate critical issues to Quality leadership in a timely manner
- Work closely with QA, QC, and Quality Systems to ensure consistent application of investigation procedures
- Facilitate communication between operations, technical teams, and quality groups during investigations
- Participate in site-level quality review boards and investigation review committees
- Identify trends across investigations and recommend systemic improvements
Qualifications:
- Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field), or an 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
- 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
Our Benefits:
- Competitive salary & equity compensation for full-time roles
- Unlimited PTO, company holidays, and quarterly mental health days
- Comprehensive health benefits including medical, dental & vision, and parental leave
- Employee Stock Purchase Program (ESPP)
- Employee discounts on hims & hers & Apostrophe online products
- 401k benefits with employer matching contribution
- Offsite team retreats