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Quality Assurance Investigations Specialist

Hims & Hers · On-site · Mesa, Arizona

Posted by Hims & Hers on their careers site · View the original posting

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The posting, as Hims & Hers wrote it

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 redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals.

ABOUT THE ROLE

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. Reporting to the Quality Assurance Manager, you will partner closely with Quality Control (QC) and Quality Systems to ensure deviations, nonconformances, complaints, and other quality events are thoroughly investigated with rigorous root cause analysis and complete documentation.

You will ensure investigations are conducted in compliance with applicable regulatory requirements, including USP <795>, <797>, and <800>.

M-F 8-5pm

KEY RESPONSIBILITIES

Event Investigation & Root Cause Analysis

  • 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.

Corrective and Preventive Actions (CAPA)

  • 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.

Compliance & Documentation

  • 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.

Cross-Functional Collaboration

  • Work closely with QA, QC, an

[…]
e time for up to a twelve hour shift. Must be able to lift up to 50lbs.

  • Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement https://www.hims.com/global-candidate-privacy-statement.