Quality Inspector
On-siteBellmore, New York, United States
Job Summary
Conduct routine and unannounced audits across compounding, pharmacy verification, fulfillment, shipping, and dispensing operations to confirm adherence to SOPs and regulatory requirements. Inspect compounded products for identity, labeling accuracy, container integrity, and documentation, while verifying order-to-fulfillment details including patient information and packing accuracy. Perform inspections for compliance with USP <795>, <797>, <800>, and <1163>, supporting HIPAA, DEA, and DSCSA regulatory standards within telehealth workflows. Document and escalate nonconformances, deviations, and quality concerns, then oversee in-process and finished product testing for potency, sterility, and stability. Analyze temperature-monitoring data from pack-out studies to support shipping configuration and carrier qualification, and review batch records and Certificates of Analysis before release. Monitor cleanroom practices, environmental monitoring, and vendor qualification documentation to prevent compliance issues and support continuous improvement initiatives.
Required Qualifications
- High school diploma or equivalent
- 1–3 years of experience in quality assurance, quality control, pharmacy, healthcare, or compounding operations
- Ability to review batch records, compounding logs, Certificates of Analysis, and fulfillment documentation for accuracy and compliance
- Strong understanding of documentation practices, inspection readiness, and quality standards
- Exceptional attention to detail with strong organizational and documentation skills
- Effective written and verbal communication skills for inspection reporting and staff feedback
- Analytical and problem-solving skills to support investigations, CAPA processes, and process improvements
- Ability to work independently while collaborating across pharmacy, fulfillment, and quality teams
- Commitment to patient safety, regulatory compliance, and continuous improvement
- Location: Bellmore/Farmingdale, NY
Desired Qualifications
- Associate's or Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Quality Management, or a related field
- Pharmacy technician, pharmaceutical inspection, compounding, or fulfillment quality experience
- Familiarity with USP <795>, <797>, <800>, <1163>, FDA 21 CFR Parts 210/211, HIPAA, DEA, DSCSA, and state board of pharmacy requirements
- Experience using inspection and monitoring tools such as balances, pH meters, environmental monitoring devices, and temperature data loggers
- Familiarity with cold-chain or temperature-controlled packaging and shipping validation, including pack-out studies
- Strong computer skills, including Google Workspace
- Familiarity with eQMS, EHRs, or pharmacy management systems
- Experience working in a fast-paced compounding pharmacy, fulfillment, or direct-to-patient healthcare environment
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