Senior Operational Quality Assurance Specialist

Role: Senior Operational Quality Assurance Specialist supporting manufacturing and CMC activities for cell and gene therapy products, ensuring compliance and quality. Responsibilities: oversee batch release processes, review and approve batch records and analytical data, perform quality checks on product attributes, manage deviations and CAPA, and support audits and regulatory submissions. Requirements: bachelor's degree in pharmaceutical sciences, life sciences, or related; 4+ years in QA within regulated biotech/pharma environments, including batch release, with experience in cGMP and GCP standards; proficiency in reviewing technical documentation and managing deviations. Preferred: advanced degree, experience in cell and gene therapy, strong regulatory knowledge (FDA, EMA, ICH), and data interpretation skills. High-Value: focus on biologics and advanced therapeutics in regulated environments, supporting regulatory compliance and continuous improvement efforts in a GMP setting. Work setup: onsite in Stafford, TX, with schedule 0700–1530, Monday to Friday.