Overview

B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Friday, Thursday, Wednesday, Tuesday, MondayShift: 5X8Relocation Available: NoRequisition ID: 14034B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit Position Summary B. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization operations within a GMP-regulated manufacturing environment. This role is responsible for reviewing sterilization records, electronic batch documentation, and quality system records to ensure compliance with regulatory requirements, Good Documentation Practices (GDP), and data integrity standards. The QA Associate partners closely with Manufacturing, Engineering, Quality, and other cross-functional teams to support product release activities, identification of quality events, and resolution of documentation discrepancies.The ideal candidate will have experience in quality, manufacturing, laboratory, or other regulated environments and possess strong attention to detail, analytical skills, and a commitment to ensuring product quality and patient safety. In This Role, You Will Have the Chance To:Review sterilization records, batch documentation, and quality records for accuracy, completeness, and compliance with GMP, GDP, and data integrity requirements.Utilize electronic systems including LIMS, MES, Wonderware, and Electronic Batch Records (EBR) to support sterilization record review and product release activities.Identify, document, and escalate deviations, nonconformances, and documentation discrepancies in accordance with established procedures.Support sterilization batch disposition and product release decisions through thorough review of quality and manufacturing records.Collaborate with Manufacturing, Quality, Engineering, and Facilities teams to resolve documentation and process-related issues.Maintain audit-ready records and support compliance with regulatory and quality system requirements.Contribute to continuous improvement initiatives that enhance quality, compliance, and operational effectiveness. Essential RequirementsHigh School Diploma or GED required.Minimum 1 year of experience supporting sterilization, quality assurance, manufacturing, or validation activities.Experience reviewing documentation for accuracy, completeness, and compliance.Working knowledge of GMPs, GDP, and quality system requirements.Strong attention to detail and commitment to data integrity.Proficiency with Microsoft Office and electronic quality systems.Strong communication, organizational, and problem-solving skills.Ability to manage multiple priorities in a fast-paced environment.Ability to work non-standard hours as business needs require. Preferred QualificationsAssociate or Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Sciences, Engineering, Quality Management, or related scientific discipline.Familiarity with deviation investigations, CAPA, nonconformance management, and product rel