QA Investigations Specialist at Hims & Hers

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 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 <795> <797> <800> FDA 503B guidance and cGMP standards.Key Responsibilities:Event Investigation & Root Cause AnalysisLead 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)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 & DocumentationPrepare 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 CollaborationWork 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.Continuous ImprovementIdentify 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.Qualifications:Education & ExperienceBachelors 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.Knowledge & SkillsBachelors 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.Proficiency in electronic quality systems (e.g. TrackWise MasterControl) preferred.Key CompetenciesAnalytical and detail-oriented mindset.Strong problem-solving and decision-making abilities.Clear and professional communication skills.High sense of accountability and ownership.Ability to work independently and in cross-functional teams.Our Benefits (there are more but here are some highlights):Competitive salary & equity compensation for full-time rolesUnlimited PTO company holidays and quarterly mental health daysComprehensive health benefits including medical dental & vision and parental leaveEmployee Stock Purchase Program (ESPP)401k benefits with employer matching contributionOffsite team retreatsWe 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 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 ourGlobal Candidate Privacy Statement.Required Experience:IC Key Skills Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration Employment Type : Full-Time Experience: years Vacancy: 1