Quality Inspector

Job Description

Job Description

At Precision Medicine , we are revolutionizing healthcare! Our mission is to empower the evolution of modern medicine by providing accessible, personalized, and efficient healthcare solutions. Join our dynamic team where your expertise matters, your ideas are valued, and your background helps shape the future of patient care. We celebrate diverse perspectives and foster an environment where you can thrive, innovate, and make a meaningful impact on patients' lives.

Job Summary

We are seeking a detail-oriented, compliance-focused Quality Inspector to support quality operations within our 503A compounding pharmacy and direct-to-consumer telehealth fulfillment operations.

This role is responsible for inspecting compounded products, materials, packaging, and processes to ensure compliance with regulatory requirements, internal quality standards, and patient safety expectations.

The Quality Inspector will support the company's Quality Management System by conducting audits and inspections across compounding, pharmacy verification, fulfillment, shipping, packaging validation, vendor qualification, third-party testing, and batch release activities.

This position reports directly to the Director of Quality and will be located on-site in Bellmore/Farmingdale, NY.

Key Responsibilities

Perform inspections and reviews that support the company's Quality Management System, regulatory standards, and business objectives.

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, documentation accuracy, and overall product quality.

Verify order-to-fulfillment accuracy, including patient information, prescription details, packing accuracy, and shipment readiness.

Inspect compounding operations for compliance with USP <795> , <797> , <800> , <1163> , and applicable state board of pharmacy requirements.

Support HIPAA, DEA, DSCSA, and pharmacy regulatory compliance within telehealth fulfillment workflows.

Document, escalate, and support the resolution of nonconformances, deviations, and quality concerns.

Design and conduct pack-out studies to confirm that products maintain required storage temperatures throughout transit.

Analyze temperature-monitoring data from pack-out studies and document findings to support shipping configuration, carrier, packaging, insulation, and coolant qualification.

Oversee in-process and finished product testing, including potency, sterility, and stability testing.

Coordinate shipment of compounded product samples to third-party testing laboratories.

Input third-party testing results into the quality software system and track outstanding results to closure.

Review testing results, supporting documentation, and Certificates of Analysis to confirm compliance before batch release.

Review batch records, compounding logs, fulfillment documentation, and quality records for accuracy, completeness, and adherence to SOPs.

Monitor cleanroom gowning, aseptic practices, environmental monitoring, and related quality procedures.

Support deviation, CAPA, and change control activities by providing inspection data and verification.

Assist in qualifying new and existing vendors and suppliers, including raw material, packaging, and testing vendors.

Collect and review vendor qualification documentation, including certifications, COAs, and quality agreements.

Support periodic vendor requalification, maintain approved vendor records, and escalate concerns identified during review.

Provide feedback to staff on observed deficiencies and reinforce best practices during inspections.

Track inspection findings, pack-out study results, testing trends, and quality metrics to support continuous improvement initiatives.

Recommend improvements to inspection methods, packaging validation processes, quality monitoring, and operational workflows.

Help prevent rework, reshipments, product loss, temperature excursions, and compliance issues by identifying and resolving quality concerns early.

Required Qualifications

High school diploma or equivalent required.

1–3 years of experience in quality assurance, quality control, pharmacy, healthcare, or compounding operations required.

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.

Preferred 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.

Job Details

Salary

Competitive; commensurate with experience.

Benefits

401(k)

401(k) Matching

Dental Insurance

Health Insurance

Paid Time Off

Vision Insurance

Schedule

Monday through Friday, 9:00 AM to 5:00 PM

Location

Bellmore/Farmingdale, NY

Why Join Us

As part of Precision Medicine, you'll be at the heart of an exciting transformation in the telemedicine landscape. Together, we're pioneering solutions that bridge technology and compassionate care, improving health outcomes for all.

We're committed to your growth, providing you with the resources and support you need to build a meaningful career while exploring your creativity.

Ready to be a part of something groundbreaking? Join us as we move healthcare forward, one innovation at a time!

Learn more at:

Equal Opportunity Statement

Precision Medicine is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve. Our associates, customers, and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

Please contact us at mailto:View email address on ziprecruiter.com to request accommodation.