Senior Quality Assurance Specialist

Role: Senior Quality Specialist supporting GMP activities for a clinical-stage biotech developing cell-based therapies for cancer and rare diseases. Responsibilities: review and ensure accuracy, completeness, and compliance of GMP documentation (including batch records, protocols, investigations, change controls, and validation documents); identify and remediate compliance gaps; support inspection readiness, internal audits, and regulatory documentation; collaborate with manufacturing and external partners to maintain quality standards; promote a quality-focused culture and continuous process improvement. Requirements: Bachelor’s in biology, chemistry, microbiology, biotech, pharmaceutical sciences, or related; 5+ years in GMP QA, document control, or manufacturing quality, with experience supporting clinical manufacturing and batch release; strong knowledge of GMP regulations, deviations, CAPAs, and analytical testing; proficient in MS Office; excellent attention to detail, risk assessment, communication, and collaboration skills. High-Value: GMP-regulated environment, clinical manufacturing support, documentation review, data integrity, quality systems, cross-functional collaboration. WorkSetup: on-site five days a week.