Incoming QA (IQA) Associate / Supplier Quality

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, drug products, syringes, and other critical supplies—to ensure compounds are properly received, inspected, documented, and released for use in accordance with USP standards (e.g., USP , USP , USP , USP ). 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 continually improving them, the IQA Associate examines incoming materials, determines release status, and works with warehousing and supply‑chain management personnel to 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.

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 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 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, in close collaboration with warehousing and supply‑chain personnel Material Release & Disposition Decisions Determine, based on established procedures, whether 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 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 Work with warehousing personnel to ensure a FEFO system is followed after release Maintain inspection records in an audit‑ready state for regulatory inspections (e.g., CoA’s, incoming material records) Follow and maintain adherence to USP , USP , USP , 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, collaborating closely 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 Support supplier qualification, audits, and ongoing performance monitoring 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 Develop and maintain supplier scorecards and quality metrics Process Improvement & System Development Help continually improve IQA procedures, inspection checklists, and acceptance criteria Identify gaps, inefficiencies, or risks in the current and/or future incoming quality function Suggest, obtain management approval, and work cross‑functionally to implement enhancements that 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 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 Initiate nonconformance reports (NCRs) and deviations for materials that fail inspection criteria Participate as part of a larger cross‑functional team in investigations to determine root cause of incoming material quality issues 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 and conformance to established CoA results 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 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 , USP , USP 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, auditing, and performance monitoring Familiarity with material testing requirements (identity, purity, sterility, etc.) Understanding of proper material storage, handling, segregation, and chain of custody Core Competencies – Critical Highly organized and detail‑oriented with exceptional attention to detail – ESSENTIAL Understanding of the importance of being one of the first lines of defense for the company – CRITICAL Ability to identify quality issues, contamination, damage, or discrepancies Sound judgment and decision‑making capabilities for material disposition Strong analytical skills to review specifications, CoAs, and testing data Excellent documentation skills with meticulous record‑keeping practices Clear communication skills for interacting with suppliers, procurement, and internal customers/teams Sense of urgency balanced with thoroughness – knowing when to move quickly vs. escalating Proactive mindset with ability to identify process improvements and system gaps Treats colleagues with courtesy and dignity Communicates with tact, diplomacy, and professionalism Models a positive, solutions‑oriented attitude Technical Skills Proficiency with Microsoft Office Suite (Excel for tracking, Word for documentation) Experience with CGMP quality management systems (QMS) or electronic quality systems (eQMS) Familiarity with inventory management systems and material procedural tracking software Ability to perform pharmaceutical calculations and verify material quantities Comfortable learning new software systems and quality tools Preferred Qualifications Experience in 503B outsourcing facilities or large‑scale compounding operations Background in pharmaceutical manufacturing or API production Previous experience with supplier audits, vendor qualification programs, or supplier scorecards Exposure to sterile product manufacturing and aseptic processing Familiarity with continuous improvement methodologies (Lean, Six Sigma) Experience supporting regulatory inspections with incoming quality documentation

WORKING CONDITIONS

This is 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 (up to 50 lbs occasionally), 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 (FIRST 12 MONTHS)

Successfully onboard and demonstrate proficiency in ReviveRX incoming quality procedures within 90 days Achieve 100% inspection and documentation of all incoming materials within established timeframes Successfully manage material volumes without compromising quality Implement at least 3‑5 process improvements or enhancements to strengthen the IQA function Develop supplier quality metrics, scorecards, or performance tracking systems Zero critical regulatory findings related to incoming material control during inspections Demonstrate measurable reduction in quality/regulatory risk through enhanced IQA practices Successfully prevent nonconforming materials from entering production through vigilant inspection Equal Employment Opportunity (EEO) and Affimative Action Commitment ReviveRX is committed to providing equal employment opportunities and render affirmative action to all employees and applicants for employment, including individuals who are members of underrepresented groups, without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or any other status protected by applicable federal, state, or local laws. Reasonable Accommodations Statement To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions. #J-18808-Ljbffr ReviveRX