QA Investigations Specialist Operations

QA Investigations Specialist

Lead root cause analysis and resolution of pharmacy quality deviations to ensure regulatory compliance

Location : Gilbert, Arizona, United States

Job Tags : Operations

About The Role

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, were 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 and . For information on the companys outstanding benefits, culture, and its talent?first flexible / remote work approach, see below and visit .

About the Role :

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 , , , FDA 503B guidance, and cGMP standards.

Key Responsibilities :

Event Investigation & Root Cause Analysis

• 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.

Corrective and Preventive Actions (CAPA)

Compliance & Documentation

Cross?Functional Collaboration

Continuous Improvement

Qualifications :

Education & Experience

Knowledge & Skills

Key Competencies

Our Benefits (there are more but here are some highlights) :

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If youre excited about this role, we encourage you to applyeven if youre 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@ 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.

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