Quality Assurance Specialist - 174010

Responsibilities: of the Quality Assurance Specialist: • Review and disposition clinical supply materials to ensure compliance with company procedures, cGMP regulations, and regulatory requirements. • Perform batch documentation reviews and support release activities for clinical finished goods used in global clinical trials. • Assist with quality investigations, deviations, CAPAs, and change control activities. • Support continuous improvement initiatives, quality process enhancements, and procedural updates. • Partner with cross-functional teams to ensure compliant clinical packaging, labeling, distribution, and supply chain operations. • Provide quality guidance and support for operational and technical issues. • Manage investigation and project timelines while identifying risks and supporting remediation efforts. • Active usage of Lean Six Sigma and our company's production system (PS) tools within problem solving and daily activities. Qualifications: of the Quality Assurance Specialist: • Bachelor's degree in a scientific, engineering, or related technical field preferred. • 5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related industry environment. • Experience with batch disposition, batch release, or clinical material review strongly preferred. • Knowledge of investigations, deviation management, CAPAs, and change controls. • Background in Quality Assurance, Quality Control, Regulatory Affairs, Technical Operations, or Manufacturing Quality. • Strong understanding of cGMP regulations and pharmaceutical quality systems. • Demonstrated analytical, problem-solving, organizational, and communication skills. • Ability to manage multiple priorities and collaborate effectively with cross-functional teams. • Proficiency with Microsoft Office applications including Excel, Outlook, Word, and PowerPoint. • Experience with systems such as TrackWise, SAP, Veeva, Documentum, QUMAS, ERP, or MES preferred Compensation: for the Quality Assurance Specialist: • Pay Rate: $40-45/hr. • Long-Term Contract Opportunity, Hybrid Schedule • Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave (as required by law), and Paid Holidays Application Period: This position opens for applications on 09/22/2026 and will remain open for a minimum of 30 days from the posting date.