Incoming QA; IQA Associate​/Supplier Quality

POSITION OVERVIEW

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, 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 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.

• 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 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

• 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

• 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

• Help Revive
  
  RX 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…