Description
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 seeking an experienced Quality Assurance Investigations Specialist to join the Quality Unit at our compounding pharmacy in New Albany, OH.
In this role, you will lead and support investigations into quality-related events within our 503A compounding pharmacy operations.
Key Responsibilities
- Event Investigation & Root Cause Analysis:
- Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS results, and other quality events.
- Investigate customer complaints and quality-related events, working closely with pharmacists to assess product 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, 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 and investigation review committees.
- Continuous Improvement:
- Identify trends across investigations and recommend systemic improvements.
- Support training of staff on deviation reporting, investigation practices, and documentation standards.
- Contribute to the enhancement of site procedures for deviation and OOS management.
Qualifications
- Education & Experience:
- Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field), or an equivalent combination of education and experience.
- 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
- Pharmacy Technician or trainee license, or willingness to obtain one.
- Knowledge & Skills:
- Strong understanding of USP <795>, <797>, and <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP; GDP and GLP experience preferred.
- Experience with investigations, deviation management, and escalation procedures.
- Excellent attention to detail, documentation practices, and organizational skills.
- Excellent written and verbal communication skills, including technical writing.
- Strong collaboration skills across multidisciplinary teams.
- Ability to manage multiple investigations under tight timelines.
- Proficiency in Google Workspace; proficiency with electronic quality systems (e.g., TrackWise, MasterControl) preferred.
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)
- 401(k) with employer matching contribution
- Offsite team retreats