Incoming QA (IQA) Associate / Supplier Quality
ReviveRX and Ways2Well
QA Associate
The Incoming QA (IQA) Associate serves as ReviveRX'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 facilityincluding APIs, excipients, production materials, drug products, syringes, and other critical supplies, and consumablesto ensure compounding materials are properly received by the warehousing staff, inspected, documented and released for use in accordance with internal procedures, USP standards, 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 ReviveRX'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.
Key responsibilities include incoming material inspection & assessment, material release & disposition decisions, documentation & compliance, supplier quality management, process improvement & system development, nonconformance & deviation management, cross-functional collaboration, material flow management, and regulatory inspection & audit support.
Qualifications include a bachelor's degree in pharmaceutical sciences, chemistry, biology, or related scientific field, 5-10 years of experience in the regulated industry, deep understanding of applicable state and federal laws and regulations, knowledge of USP standards, highly organized and detail-oriented with exceptional attention to detail, strong analytical skills, excellent documentation skills, clear communication skills, sense of urgency balanced with thoroughness, proactive mindset, treats colleagues with courtesy and dignity, communicates with tact, diplomacy, and professionalism, models a positive, solutions-oriented attitude, proficiency with Microsoft Office Suite, experience with CGMP quality management systems, familiarity with inventory management systems, ability to perform pharmaceutical calculations, comfortable learning new software systems and quality tools.
Working conditions include an on-site position based in Houston, Texas, requiring daily presence to inspect incoming materials, access warehouse/receiving areas, and interact with operations and quality teams. Standard business hours with flexibility to coordinate with receiving schedules and second shift operations as needed. The role involves physical activity including lifting and moving materials, visual inspection in warehouse environments, and sustained focus reviewing documentation. Work is conducted in both climate-controlled office areas and warehouse/receiving environments. Safety equipment and proper handling procedures must be followed when inspecting materials.
Success metrics for the first 12 months include successfully onboarding and demonstrating proficiency in ReviveRX incoming quality procedures, achieving 100% inspection and documentation of all incoming materials, successfully managing material volumes without compromising quality, implementing process improvements or enhancements to strengthen the IQA function, developing supplier quality metrics, scorecards, or performance tracking systems, zero critical regulatory findings related to incoming material control during inspections, demonstrating measurable reduction in quality/regulatory risk through enhanced IQA practices, and successfully preventing nonconforming materials from entering production through vigilant inspection.
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