Incoming QA (IQA) Associate / Supplier Quality

 
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. 

 
POSITION OVERVIEW 
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 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 <797> Pharmaceutical Compounding – Sterile Preparations, USP <795> Pharmaceutical Compounding – Non-Sterile Preparations, USP <800> Hazardous Drugs, USP <1163> 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 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 
Incoming Material Inspection & Assessment 
•Assess the quality of all incoming components received at ReviveRX, 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 
 
Material Release & Disposition Decisions 
•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 
 
Documentation & Compliance 
•Maintain complete, accurate, and approved coordinated and controlled chain-of-custody (from receipt to initial quarantine to release/reject, etc.) for all incoming inspections 
•Review and verify Certificates of Analysis (CoA's) and/or other applicable documentation for conformance to specifications 
•Ensure all materials are properly labeled, logged, and traceable in the inventory system 
•Verify expiration dates, lot numbers, and retest dates are documented and monitored 
•Ensure, in close collaboration with warehousing personnel, that a FEFO (first expired/first out) system is followed after the material is released for use 
•Maintain inspection records in an audit-ready state for regulatory inspections (e.g., CoA's, incoming material records, etc.) 
•Follow and maintain adherence to USP <797>, USP <795>, USP <800>, as well as all State and Federal laws and regulations 
 
Supplier Quality Management 
•Help ReviveRX continually improve the IQA function through supplier quality management expertise, in very close collaboration with warehousing and supply chain personnel 
•Track and trend supplier performance, quality issues, and nonconformances 
•Communicate quality issues and rejections to suppliers and coordinate corrective actions, in collaboration with other warehousing, supply chain, operations and quality assurance personnel 
•Support supplier qualification, audits, and ongoing performance monitoring, in close collaboration with ReviveRX's supply chain function 
•Recommend supply chain/supplier improvements, alternate sources, or disqualification based on quality performance 
•Work with procurement and quality teams to strengthen supplier quality agreements and specifications, as required 
•Develop and maintain supplier scorecards and quality metrics 
 
Process Improvement & System Development 
•Help continually improve and continually improve IQA procedures, inspection checklists, and acceptance criteria 
•Identify gaps, inefficiencies, or risks in the current and/or future incoming quality function 
•Suggest, get management approval and work cross-functionally to recommend and implement enhancements to strengthen the IQA system and reduce quality/regulatory risk 
•Help further develop or improve standard operating procedures (SOPs) for incoming material inspection 
•Implement best practices from pharmaceutical industry experience to help further elevate ReviveRX's IQA function 
•Support the implementation of electronic quality management systems for incoming quality 
 
Nonconformance & Deviation Management 
•Identify and document nonconforming materials, damaged shipments, or specification failures 
•Help to initiate nonconformance reports (NCRs) and deviations for materials that fail inspection criteria 
•Participate, as part of a larger cross-functional team, in the coordination of investigations to determine root cause of incoming material quality issues and working to ensure complete and thorough investigations 
•Work with suppliers to implement adequate corrective and/or preventive actions (CAPAs) 
•Track effectiveness of supplier CAPAs and verify closure 
•Escalate recurring supplier quality issues to management for potential supplier changes 
 
Cross-Functional Collaboration 
•Work closely with Warehousing, Supply Chain/Purchasing to communicate material status, conformance to established CoA results, and quality issues 
•Coordinate with Quality Control on testing requirements and verification 
•Partner with Operations/Compounding to understand material needs and usage requirements 
•Collaborate with Quality Assurance, Supply Chain and other Quality personnel on specifications, procedures, and compliance issues 
•Support Regulatory Affairs with supplier documentation for inspections and audits 
•Communicate hold or rejection statuses promptly to prevent production delays 
 
Material Flow Management 
•Manage the volume of incoming materials, while adhering to high quality standards 
•Prioritize inspections based on production needs, material criticality, and expiration dates 
•Ensure timely turnaround of incoming inspections to prevent production bottlenecks 
•Develop efficient workflows to handle material volumes without compromising quality 
•Maintain composure and attention to detail under pressure 
 
Regulatory Inspection & Audit Support 
•Maintain incoming quality records in an inspection-ready state at all times 
•Support FDA, state board, internal/external audits by providing incoming material documentation, as required 
•Demonstrate defensible incoming quality practices during regulatory inspections 
•Respond to audit findings or observations related to incoming quality with corrective actions 
•Ensure the IQA function meets all regulatory expectations and industry practices 
 
QUALIFICATIONS 
Education 
•Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or related scientific field - REQUIRED 
•Advanced degree (Master's, PharmD) preferred but not required 
•High school diploma with exceptional relevant experience may be considered 
 
Experience - CRITICAL REQUIREMENTS 
•5-10 years of experience in the regulated industry (compounding and/or pharma) - REQUIRED 
•Pharmaceutical industry experience preferred over compounding pharmacy 
•Operational and/or quality experience in a regulated environment - REQUIRED 
•Direct experience with incoming material inspection, quality control, or receiving operations 
•Supplier quality experience to help improve the IQA function - HIGHLY DESIRED 
•Background in raw material qualification, vendor management, or supplier auditing 
•Experience with certificate of analysis (CoA) review and material release decisions 
 
Technical Expertise 
•Deep understanding of applicable state and federal laws and regulations pertaining to assessment, quarantine, release/reject and overall incoming material control 
•Knowledge of USP <797>, USP <795>, USP <800> for compounding operations 
•Familiarity with applicable State and Federal regulations for pharmacy compounding and/or CGMP pharmaceutical manufacturing 
•Understanding of API specifications, excipient standards, and material acceptance criteria 
•Knowledge of supplier qualification, auditi