Hims AND Hers
QA Investigations Specialist
Gilbert, Arizona · Full-time
Sponsorship not specifiedDetected 1 day ago
GMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingWriting
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Lottery odds40
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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.
Responsibilities
- Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS, and other quality events.
- Perform structured root cause analyses to determine true causes.
- Collaborate with production, QC laboratory, and QA to gather evidence and assess event impact.
- Maintain complete records to support regulatory inspections and internal audits.
- Support training of staff on deviation reporting, investigation practices, and documentation standards.
- No two people are the same, so we provide access to personalized care designed for results.
Requirements
- 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
- Knowledge & Skills
- Experience with investigations, deviation management, and escalation procedures.
- Proficiency in Google Workspace and familiarity with quality systems software.
- Ability to work independently and in cross-functional teams.
- Education & Experience
- Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience.
- 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.
- 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 have
- Strong understanding of USP <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP.
- GDP and GLP practices preferred.
- Proficiency in electronic quality systems (e.g., TrackWise, MasterControl) preferred.
Compensation
- Competitive salary & equity compensation for full-time roles
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
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.
- Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability.
- 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.
- By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve.
- 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.
Equal opportunity
- 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.
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