QA Specialist

Position: QA Specialist Duration: 6 + months (Possible to extension) Location: Houston, TX Sunday to Thursday, 11 PM - 8 AM Job Description: The QA Specialist Level II-Quality Operations represents the QA department ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools. Supports corrective actions and change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management, and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance. Verify the company's compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate. provide oversight for compliance of CAPA and minor deviations. Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs. Support activities that involves QA presence on the floor. Review Master Batch Records (MBR) and supporting documents to support batch disposition. Perform review/release of Buffer/ media as needed. Perform other duties as assigned. GMP experience in the biologics and pharma industry. Working knowledge of equipment/facilities qualifications, GMP and GDP environment Entry Level - 0-4 years Skills Experience in a biopharmaceutical manufacturing environment Experience in equipment / facilities / utilities validation activities Strong experience in GDP

Created: 2026-04-02