USAQA Investigations Specialist
1 мес. назад
USAMiddleOnsite
root cause analysisquality assurancequality controldocumentation
Responsible for leading and supporting quality-related investigations in compounding pharmacy operations ensuring compliance with regulatory requirements.
Обязанности
- 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.
Условия
- 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
- 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@ 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 .
Другое
- 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 and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.
- 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.
- 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.
- Proficiency in electronic quality systems (e.g., TrackWise, MasterControl) preferred.
- Analytical 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.