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 SummaryB. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization and product release activities within a GMP-regulated manufacturing environment. This role is responsible for reviewing sterilization records, 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, Facilities, and Quality teams to support product disposition, release activities, and resolution of quality events. 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 review and release activities.Identify, document, and escalate deviations, nonconformances, and documentation discrepancies in accordance with established procedures.Verify sterilization documentation and traceability records to support product release decisions.Collaborate with Manufacturing, Quality, Engineering, and Facilities teams to resolve quality and documentation issues.Support product disposition and release activities while maintaining audit-ready records.Participate in continuous improvement initiatives to enhance compliance and operational efficiency. Essential RequirementsHigh School Diploma or GED required.Minimum one (1) year of experience in manufacturing, quality, laboratory, or FDA-regulated environments.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 organizational, analytical, and problem-solving skills.Ability to work non-standard hours as business needs require.Regular and predictable onsite attendance required. Preferred QualificationsAssociate or Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Sciences, Engineering, Quality Management, or a related scientific discipline.Experience working in pharmaceutical, medical device, biotechnology, or other regulated manufacturing environments.Familiarity with sterilization processes, validation principles, CAPA, deviation investigations, and nonconformance management.Experience with LIMS, MES, Wonderware, Electronic Batch Records, or similar quality systems.Knowledge of FDA regulations, including 21 CFR Part 11 and cGMP requirements. Knowledge & SkillsAbility to interpret procedures, specifica