Hiring: Quality Assurance Specialist IV Company: Lonza Location: Houston, TX Job Posted Time: 2026-09-03 14:48:05 Employment Type: On-site Target Skills & Keywords : Microsoft Office, Quality Assurance, Risk Management, Root Cause Analysis, SAP About the job Experience: •5+ years in Quality Assurance within a GMP-regulated biopharmaceutical, cell therapy, or related manufacturing environment. Required Skills: •Provide QA support and oversight for Cell Therapy manufacturing operations to ensure compliance with cGMP requirements and site procedures. •Conduct QA walkthroughs and on-the-floor quality oversight activities; partner with manufacturing and support groups to identify, investigate, and resolve operational issues. •Support deviation management, CAPA development, investigation activities, and change control processes as either record owner or QA approver. •Review and approve GMP documentation generated by Manufacturing, QC, Material Management, Facilities & Engineering, and other supporting departments. •Perform material release and lot disposition activities in accordance with approved procedures and quality requirements. •Represent Quality Assurance in internal and external client meetings to ensure quality expectations and regulatory requirements are met. •Track and manage quality system records to support timely closure and compliance objectives. •Support internal audits, customer audits, regulatory inspections, and inspection readiness initiatives. Qualifications: •Perform Quality Assurance review and approval of GMP documents, including master documents, executed production records, deviations, investigations, CAPAs, change controls, and controlled documents. •Bachelor’s degree in Biology, Biotechnology, Life Sciences, Engineering, or a related scientific discipline is required. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!