Quality Inspector

About the role

Precision Medicine is seeking a detail‑oriented Quality Inspector to support quality operations in our 503A compounding pharmacy and direct‑to‑consumer telehealth fulfillment sites. The role is on‑site in Bellmore/Farmingdale, NY, and reports to the Director of Quality.

Key responsibilities

• Perform routine and unannounced audits of compounding, pharmacy verification, fulfillment, shipping, and dispensing processes.
• Inspect compounded products for identity, labeling accuracy, container integrity, and documentation compliance.
• Verify order‑to‑fulfillment accuracy, including patient information and prescription details.
• Ensure compliance with USP, state board of pharmacy, HIPAA, DEA, and DSCSA regulations.
• Document, escalate, and resolve non‑conformances, deviations, and quality concerns.
• Design and conduct pack‑out studies to validate temperature control during transit.
• Analyze temperature‑monitoring data and qualify shipping configurations.
• Oversee in‑process and finished‑product testing (potency, sterility, stability) and coordinate sample shipments to third‑party labs.
• Enter third‑party testing results into the quality software system and track closure.
• Review batch records, compounding logs, and certificates of analysis before batch release.

Required profile

• Experience working in a compounding pharmacy or similar regulated environment.
• Strong knowledge of USP standards, state pharmacy board requirements, and federal regulations (HIPAA, DEA, DSCSA).
• Ability to conduct audits, document findings, and drive corrective actions.
• Familiarity with temperature‑monitoring protocols and pack‑out study design.
• Experience with potency, sterility, and stability testing procedures.

Required skills

• USP compliance
• HIPAA compliance
• DEA compliance
• DSCSA compliance
• Temperature monitoring and data analysis
• Pack‑out study design
• Potency testing
• Sterility testing
• Stability testing
• Quality management system audits