Incoming QA (IQA) Associate

ReviveRX and Ways2Well•Houston, TX

8d•Onsite

About The Position

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 facilityâincluding APIs, excipients, production materials, materials, drug products, syringes, and other critical supplies, and consumablesâto 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 â Sterile Preparations, USP <795> Pharmaceutical Compounding â 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.

Requirements

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or related scientific field - REQUIRED
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
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, auditing, and performance monitoring
Familiarity with material testing requirements (identity, purity, sterility, etc.)
Understanding of proper material storage, handling, segregation, and chain of custody
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 thoroughnessâknowing when to move quickly vs. escalate
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
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

Nice To Haves

Advanced degree (Master's, PharmD) preferred but not required
High school diploma with exceptional relevant experience may be considered
Background in raw material qualification, vendor management, or supplier auditing
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

Responsibilities

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 â 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, 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
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
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
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
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
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
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