QA Investigations Specialist
Job description
QA Investigations Specialist at hims-and-hers.
About the role
This position involves leading and supporting investigations into quality issues within both 503A and 503B compounding pharmacy operations. You will work with various quality teams to conduct thorough root cause analyses, document findings, and resolve deviations, nonconformances, and out-of-specification results. The role ensures all investigations meet regulatory requirements and company standards.
Key facts
What you'll do
- Lead and document investigations for deviations, nonconformances, complaints, and out-of-specification results.
- Conduct structured root cause analyses to identify the underlying causes of quality events.
- Ensure investigations are started, progressed, and closed within established quality system timelines.
- Work with production, quality control, and quality assurance to gather evidence and assess event impact.
- Propose and recommend corrective and preventive actions (CAPAs) to prevent future issues.
- Confirm CAPA actions are practical, risk-based, and align with regulatory and company guidelines.
- Monitor CAPA implementation and verify their effectiveness.
- Prepare clear, accurate, and compliant investigation reports following internal procedures and regulatory requirements.
- Maintain complete records for regulatory inspections and internal audits.
- Escalate critical issues to Quality leadership promptly.
- Collaborate with QA, QC, and Quality Systems to apply consistent 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 suggest systemic improvements.
- Support staff training on deviation reporting, investigation practices, and documentation.
- Contribute to improving site procedures for deviation and out-of-specification management.
Requirements
- Bachelor's degree in a science, quality, or engineering-related field, or equivalent education and experience.
- 3+ years of experience in quality, manufacturing, or a regulated industry (can substitute for a degree).
- Strong understanding of USP <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP.
- Excellent attention to detail, documentation practices, and organizational skills.
- Experience with investigations, deviation management, and escalation procedures.
- Proficiency in Google Workspace.
- Strong interpersonal and communication skills, both written and verbal.
- Pharmacy Technician or trainee license, or willingness to acquire one.
- Excellent technical writing skills.
- Strong collaboration skills for multidisciplinary teams.
- Ability to manage multiple investigations under tight deadlines.
Nice to have
- Familiarity with quality systems software.
- Knowledge of GDP and GLP practices.
- Proficiency in electronic quality systems (e.g., TrackWise, MasterControl).
Skills & tools
- Google Workspace
- Quality systems software (preferred)
- TrackWise (preferred)
- MasterControl (preferred)
Practical notes
Benefits include unlimited PTO, company holidays, quarterly mental health days, comprehensive health benefits (medical, dental, vision), parental leave, Employee Stock Purchase Program (ESPP), and 401k with employer matching. The company offers offsite team retreats. Hims & Hers is an equal opportunity employer and provides reasonable accommodations for qualified individuals with disabilities.