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QA Investigations Specialist
Hims & HersTelemedicine company
Gilbert, United StatesMid
Thrive Capital
Forerunner Ventures
8VC
Software Engineering
About the role
TL;DR
Investigates quality-related events in compounding pharmacy operations.
- •The Investigations Specialist is responsible for leading and supporting investigations into quality-related events within both 503A and 503B compounding pharmacy operations.
- •This role collaborates with Quality Assurance (QA), Quality Control (QC), and Quality Systems to ensure thorough root cause analysis, documentation, and resolution of deviations, nonconformances, out-of-specification (OOS) results, and other quality events.
- •Key Responsibilities Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS, 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.
- •Identify and recommend appropriate CAPAs to prevent recurrence of issues.
- •Prepare clear, accurate, and compliant investigation reports in accordance with internal SOPs and regulatory requirements.
- •Requirements Bachelor’s degree preferred in a relevant discipline or equivalent combination of education and experience. 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
- •Strong understanding of USP , , standards, FDA 503B guidance, and cGMP.
- •Experience with investigations, deviation management, and escalation procedures.
- •Proficiency in Google Workspace and familiarity with quality systems software.
Nice-to-have skills
JiraConfluence
Domain expertise
healthcare
Benefits & perks
Competitive salary & equity compensation, Unlimited PTO, Company holidays, Quarterly mental health days, Comprehensive health benefits, Medical, dental & vision, Parental leave, Employee Stock Purchase Program (ESPP), 401k benefits with employer matching contribution, Offsite team retreats
Tech stack
JiraConfluence