Incoming Quality Assurance Technician

AP MAX INC•Houston, TX

8h•$60,000•Onsite

About The Position

The Incoming Quality Assurance Technician plays a vital role in safeguarding product quality and patient safety by performing detailed inspections, verifications, and documentation of all incoming raw materials, active pharmaceutical ingredients (APIs), excipients, containers, closures, and supplies used in sterile and nonsterile compounding. This position ensures compliance with USP <797> (sterile preparations), USP <795> (non-sterile), USP <800> (hazardous drugs), state board of pharmacy regulations, and internal standard operating procedures (SOPs) in a 503A compounding pharmacy environment. The technician works closely with the Quality Department, inventory team, and compounding staff to prevent the use of substandard materials.

Requirements

High school diploma or GED required; Associate’s degree or certification in pharmacy, quality assurance, laboratory science, or related field preferred.
Pharmacy Technician registration/licensure with the Texas State Board of Pharmacy (or eligibility to obtain) required.
Minimum 1–2 years of experience in a pharmacy, pharmaceutical, or compounding setting; experience in incoming quality control/inspection in a 503A/503B compounding pharmacy highly preferred.
Strong attention to detail and organizational skills for accurate documentation and record keeping.
Basic understanding of pharmaceutical quality principles, GDP, and deviation management.
Proficiency with Microsoft Office (Excel, Word) or similar, pharmacy/inventory management software.
Good communication skills to report issues clearly to pharmacists and/or supervisors.
Ability to read and interpret COAs, specifications, and SOPs.
Knowledge of safe handling of hazardous drugs and controlled substances preferred.

Responsibilities

Perform incoming inspections of raw materials, APIs, excipients, sterile components (vials, stoppers, syringes), filters, and other supplies upon receipt, verifying quantities, identity, condition, labeling, and integrity against purchase orders and specifications.
Review and approve supplier documentation, including Certificates of Analysis (COAs), Certificates of Conformance (COCs), material safety data sheets (MSDS/SDS), and vendor qualification records to ensure materials meet pharmacopeial standards (USP/NF) and pharmacy requirements.
Conduct visual inspections, dimensional checks, and basic testing on incoming items; quarantine non-conforming materials and initiate deviation reports.
Sample incoming materials per approved sampling plans and coordinate sending samples for third party testing (e.g., identity, potency, endotoxin, sterility) when required.
Release approved materials into inventory after verification, label and store materials under proper controlled conditions (temperature, humidity, light protection, segregation of hazardous vs. non-hazardous).
Maintain accurate and complete documentation in electronic systems or logs, including incoming inspection reports, quarantine logs, release records, and traceability documentation in compliance with good documentation practices (GDP).
Investigate and document discrepancies, damaged shipments, or out of specification results; collaborate on root cause analysis and corrective actions under QA supervision.
Support supplier qualification and auditing activities by collecting and organizing vendor data.
Assist in environmental monitoring of receiving/storage areas and ensure proper segregation of incoming vs. released materials to prevent mix ups or contamination.
Participate in internal audits, regulatory inspections, and continuous improvement initiatives related to incoming quality processes.
Follow strict gowning, hygiene, and safety protocols when handling materials, including hazardous drugs per USP <800>.