QA Investigations Specialist

hims & hers • Gilbert, AZ

47d

About The Position

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. The position ensures that investigations are conducted in compliance with applicable regulatory requirements, including USP <795>, <797>, <800>, FDA 503B guidance, and cGMP standards.

Requirements

• 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.
• 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.
• Strong understanding of USP <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP. GDP and GLP practices preferred.
• Excellent attention to detail, documentation practices, and organizational skills.
• Experience with investigations, deviation management, and escalation procedures.
• Proficiency in Google Workspace and familiarity with quality systems software.
• Strong interpersonal and communication skills (written and verbal).
• Pharmacy Technician or trainee license or willingness to acquire.
• Excellent written communication and technical writing skills.
• Strong collaboration skills across multidisciplinary teams.
• Ability to manage multiple investigations under tight timelines.

Nice To Haves

• Proficiency in electronic quality systems (e.g., TrackWise, MasterControl) preferred.

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.
• Collaborate with production, 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 or 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 enhancement of site procedures for deviation and OOS management.

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)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Health and Personal Care Retailers