Incoming QA; IQA Associate

ReviveRX is the premier licensed pharmacy specializing in health, wellness, and restorative medicine. We focus on treating the source, not just the symptoms, utilizing industry-leading technology. Collaborating with innovative pharmacists, healthcare providers, and pharmaceutical manufacturers, we provide personalized care. Our mission is to optimize treatment, revolutionize healthcare, and empower individuals to live vibrant lives. We welcome you to join us in our commitment to holistic wellness and personalized medicine.

The Incoming QA (IQA) Associate serves as Revive

RX's first line of defense to ensure fit-for-use material and components are released for use in the facility. They assess the quality of all incoming components entering the facility—including APIs, excipients, production materials, materials, drug products, syringes, and other critical supplies, and consumables—to ensure compounding materials are properly received by the warehousing staff, inspected, documented and released for use in accordance with internal procedures, USP standards (e.g., USP Pharmaceutical Compounding – Sterile Preparations, USP Pharmaceutical Compounding – Non-Sterile Preparations, USP Hazardous Drugs, USP Quality Assurance in Pharmaceutical Compounding, etc.).

This is a critical patient safety role requiring meticulous attention to detail, strong organizational skills, and the ability to assess component quality against established specifications and procedures. Following established procedures and helping to continually improve them, the IQA Associate examines incoming materials, determines release status, and works with warehousing and supply chain management personnel to further strengthen Revive

RX's incoming quality function. The ideal candidate brings 5-10 years of experience in the regulated industry (compounding and/or pharma, with pharma preferred), operational and/or quality experience, and supplier quality expertise to help further improve this critical function.

Revive

RX currently has an IQA associate; however, there is a need for this role to further strengthen our incoming quality function. The person in this role needs operational and/or quality experience, must be highly organized and detail-oriented, and must understand the importance of being Revive

RX's first line of defense. Additionally, supplier quality experience is essential to help continue to improve and mature the IQA function.

• Assess the quality of all incoming components received at Revive
  
  RX, including APIs, excipients, production materials, drug products, syringes, packaging materials, and other supplies
• Conduct thorough visual inspections for damage, contamination, labeling accuracy, and general condition
• Re-verify (after warehousing personnel) that received materials match purchase orders, packing slips, and Certificates of Analysis (CoA's) and/or other applicable documentation
• Ensure incoming materials are segregated/quarantined (until a release decision has been made by quality) from already released materials – to avoid potential mix-ups
• Ensure components are stored under appropriate conditions (temperature, humidity, light protection) upon receipt
• Examine incoming materials to ensure they are fit-for-use in sterile and non-sterile compounding operations
• Identify and reject any materials that do not meet acceptance criteria, all in close collaboration with warehousing and supply chain personnel

• Following established procedures, determine if components can be released for use in compounding operations
• Make disposition decisions (approve, reject from quarantine, hold for testing, hold for investigation) based on inspection results and specifications
• Document all inspection findings, release decisions, and rationale
• Coordinate with Quality Control for any required testing or verification of questionable materials
• Escalate complex or high-risk disposition decisions to quality management
• Ensure only approved, fit-for-use materials are released to operations

• Maintain complete,…