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Quality Assurance Investigations Specialist

Hims & Hers· QUALITY
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Mesa, Arizona, Gilbert, ArizonaFull-timePosted 4d ago

About the role

Experienced QA investigations specialist needed to lead and support investigations into quality-related events within a 503A compounding pharmacy operations. Ensures deviations, nonconformances, complaints, and other quality events are thoroughly investigated with root cause analysis and complete documentation, compliant with USP <795>, <797>, and <800> and applicable regulatory requirements.

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 CAPAs to prevent recurrence of issues
  • Ensure CAPA actions are practical, risk-based, and aligned with regulatory and company standards
  • Track CAPA implementation and verify effectiveness
  • 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
  • Support training of staff on deviation reporting, investigation practices, and documentation standards
  • Contribute to the enhancement of site procedures for deviation and OOS management

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

Skills

Required:Root Cause AnalysisCAPA ManagementRegulatory ComplianceDocumentation & Technical WritingCross-Functional Collaboration

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
Last updated Oct 21, 2026. Interested? Apply on the company site.

About Hims & Hers

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