B. Braun is looking for Quality Assurance Associate I, Sterilization Assurance in Irvine, CA.
This local job opportunity with ID 3939509569 is live since 2026-11-03 17:21:59.
B. Braun is seeking a QA Associate I, Sterilization Assurance to support the safety and quality of healthcare products in our biotechnology and pharmaceutical operations. In this role, you will execute sterilization assurance testing, support validation studies, and help monitor routine sterilization processes in accordance with cGMP, FDA, and ISO 13485 standards. You will document results, support investigations, and collaborate closely with quality, engineering, and manufacturing teams. B. Braun offers a collaborative culture focused on continuous learning, safety, and innovation, providing strong opportunities for professional growth. Execute sterilization assurance tests and studies for medical and pharmaceutical products following SOPs and regulatory standards Support validation and routine monitoring of sterilization processes to ensure product safety and compliance Document test methods, results, deviations, and CAPAs in accordance with cGMP and quality system requirements Collaborate with manufacturing, engineering, and quality teams to investigate nonconformances and implement improvements Assist in maintaining lab equipment, environmental controls, and sterility assurance documentation Participate in audits, inspections, and continuous improvement initiatives related to sterilization assurance Sterilization validation and assurance Microbiology testing techniques (bioburden, sterility, BI testing) Data analysis and documentation under cGMP Understanding of ISO 11135/11137 and ISO 13485 Deviation, CAPA, and change control documentation Laboratory equipment operation and calibration Environmental monitoring in controlled environments Technical writing for protocols and reports Statistical analysis of process and test data Regulated industry compliance (FDA, EU MDR) Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k Knowledge of ISO 11135/11137 or related sterilization standards Familiarity with cGMP, FDA, and ISO 13485 quality system requirements Microbiology or sterilization science coursework or lab experience preferred5c143e31-5e48-4549-b638-05792d185386
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