Quality Inspector

About the Role

Precision Medicine is focused on advancing healthcare through accessible, personalized, and efficient solutions. The company values diverse viewpoints, encourages innovation, and aims to improve patient outcomes through modern medicine and compassionate care.

Job Summary

This opening is for a meticulous, compliance-driven Quality Inspector to support quality activities in a 503A compounding pharmacy and direct-to-consumer telehealth fulfillment environment. The position is based on-site in Bellmore/Farmingdale, NY and reports to the Director of Quality.

What You’ll Do

You will help maintain the Quality Management System by auditing, inspecting, documenting findings, and supporting resolution of quality issues across compounding, verification, fulfillment, shipping, packaging validation, vendor qualification, third-party testing, and batch release workflows.

• Carry out planned and surprise inspections across compounding, pharmacy verification, fulfillment, shipping, and dispensing activities to confirm SOP and regulatory adherence.
• Examine compounded products for correct identity, labeling, container integrity, documentation accuracy, and overall quality.
• Check order-to-fulfillment accuracy, including patient details, prescription information, packing correctness, and readiness for shipment.
• Review compounding activities for compliance with USP standards, applicable state board of pharmacy rules, and related quality requirements.
• Support HIPAA, DEA, DSCSA, and pharmacy compliance within telehealth fulfillment processes.
• Record, escalate, and help close nonconformances, deviations, and other quality concerns.
• Plan and perform pack-out studies to verify that products remain within required temperature ranges during transit.
• Evaluate temperature-monitoring data from pack-out studies and document conclusions that inform shipping setup, carrier selection, packaging, insulation, and coolant qualification.
• Oversee testing for in-process and finished goods, including potency, sterility, and stability checks.
• Arrange shipment of compounded samples to external testing laboratories.
• Enter third-party test outcomes into quality software and follow up on unresolved results until closure.
• Review test reports, supporting documents, and Certificates of Analysis before approving batch release.
• Audit batch records, compounding logs, fulfillment paperwork, and quality documentation for completeness, correctness, and SOP compliance.
• Observe cleanroom gowning, aseptic behavior, environmental monitoring, and related quality procedures.
• Support deviation, CAPA, and change control work by supplying inspection data and verification findings.
• Help assess new and current vendors and suppliers, including raw material, packaging, and testing partners.
• Collect and review vendor qualification records such as certifications, COAs, and quality agreements.
• Assist with periodic vendor requalification, maintain approved vendor files, and raise issues found during review.
• Give constructive feedback to staff on observed gaps and reinforce better practices during inspections.
• Track inspection outcomes, pack-out results, testing trends, and quality metrics to drive continuous improvement.
• Suggest ways to improve inspection techniques, packaging validation, quality monitoring, and operational workflows.
• Help reduce rework, reshipments, product waste, temperature excursions, and compliance risks by catching and resolving issues early.

Required Qualifications

The role calls for a high school diploma or equivalent, plus 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 documents for accuracy and compliance.
• Strong grasp of documentation practices, inspection readiness, and quality standards.
• Excellent attention to detail along with strong organizational and recordkeeping skills.
• Clear written and verbal communication skills for reporting findings and giving feedback.
• Analytical thinking and problem-solving ability to support investigations, CAPA, and process improvement.
• Capability to work independently while coordinating with pharmacy, fulfillment, and quality teams.
• Strong commitment to patient safety, regulatory compliance, and ongoing improvement.

Preferred Qualifications

Preferred background includes an associate’s or bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Quality Management, or a related discipline, plus experience in pharmacy technician work, pharmaceutical inspection, compounding, or fulfillment quality.

• Familiarity with USP standards, 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.
• Knowledge of cold-chain or temperature-controlled packaging and shipping validation, including pack-out studies.
• Strong computer proficiency, including Google Workspace.
• Exposure to eQMS platforms, EHRs, or pharmacy management systems.
• Experience in a fast-paced compounding pharmacy, fulfillment, or direct-to-patient healthcare setting.

Job Details

This is a full-time, on-site role in Bellmore/Farmingdale, NY. The schedule is Monday through Friday, 9:00 AM to 5:00 PM. Compensation is competitive and based on experience.

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Why Join Us

You’ll be part of a team working to reshape telemedicine and modern healthcare. The organization emphasizes growth, creativity, and the chance to contribute to meaningful progress in patient care.

Equal Opportunity and Accommodation

Precision Medicine is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other protected characteristics. The company also provides reasonable accommodations for people with disabilities during the application or interview process, to perform essential job duties, and to access employment benefits and privileges. Accommodation requests can be sent to recruiting@mypcphealth.com.