Quality Compliance Specialist, Post Market Surveillance
New
H
Hims & HersHealth and Wellness
US Remote, Preferably work in the EST time zoneFull-TimeMiddle
Salary$90K - $115K
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Job Details
- Experience
- 4+ years of experience
- Required Skills
- ComplianceQuality AssuranceZendesk
Requirements
- 4+ years of experience in pharmacy operations, quality assurance, or complaint handling in a regulated environment.
- Familiarity with 503A/503B compounding pharmacy regulations and FDA reporting requirements.
- Knowledge of 21 CFR Parts 210/211, cGMP, and GDP practices.
- Understanding of USP <795> and <800> standards and non-sterile compounding processes.
- Experience with complaint or case management platforms (e.g., Zendesk).
- Strong oral and written communication skills.
- Excellent analytical skills to identify trends and root causes.
- Active Pharmacy Technician or Pharmacist license preferred.
- Bachelor’s degree preferred in a science, quality, or engineering field, or associate degree with equivalent experience.
- High sense of accountability and collaborative mindset.
Responsibilities
- Ensure customer complaints are independently investigated, documented, and communicated to stakeholders.
- Triage and route complaints to appropriate third parties based on product and dispensing location.
- Evaluate third-party pharmacy investigation reports for root cause analysis and quality standards.
- Determine regulatory reportability of events under 503A/503B classification and FDA requirements.
- Track complaint deadlines against contractual and regulatory timelines.
- Analyze complaint trends across categories like packaging and cold chain to recommend process changes.
- Create and present metric reports on complaint trends, root cause analysis, and action plans to leadership.
- Lead cross-functional meetings with customer experience, pharmacy operations, R&D quality, and medical affairs.
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