Overview

B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Wednesday, Tuesday, Friday, Thursday, MondayShift: 5X8Relocation Available: NoRequisition ID: 12095B. 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 The QAO Chemistry Specialist II provides Quality Assurance oversight of Quality Control laboratory operations and quality systems to ensure compliance with regulatory requirements and internal standards. This role is responsible for reviewing analytical testing data, laboratory records, and quality documentation supporting product release activities while ensuring data integrity and GMP compliance. The ideal candidate will have a strong QA/QC Chemistry background with expertise in analytical techniques including HPLC, UPLC, GC, FTIR, and Wet Chemistry. This position partners closely with Quality Control, Manufacturing, and Corporate Quality teams to support investigations, compliance initiatives, and continuous improvement efforts. In This Role, You Will Have the Chance To: Provide Quality Assurance oversight of Quality Control laboratory operations and quality systems to ensure GMP and regulatory compliance. Review and approve analytical data, laboratory documentation, protocols, reports, and records supporting product release activities. Review testing data generated using HPLC, UPLC, GC, FTIR, and Wet Chemistry methods to ensure accuracy, compliance, and data integrity. Utilize Empower, LabWare LIMS, SAP, and TrackWise to support data review, investigations, and quality processes. Support and approve deviations, investigations, OOS/OOT events, CAPAs, change controls, and validation activities while driving continuous improvement initiatives. Essential Requirements Bachelor's degree or equivalent combination of education and experience required. Minimum of 6 years of experience, preferably within pharmaceutical, biotechnology, medical device, or related manufacturing environments. Strong Quality Assurance and/or Quality Control Chemistry background with experience reviewing analytical data and laboratory records. Comprehensive knowledge of HPLC, UPLC, GC, FTIR, and Wet Chemistry methodologies. Experience with LabWare LIMS, SAP (ERP), TrackWise, and Empower Chromatography Data System. Strong knowledge of GMPs, FDA regulations, ICH guidelines, and data integrity principles. Excellent problem-solving, organizational, and communication skills. Preferred Experience Includes Experience supporting laboratory investigations, deviations, CAPAs, and change controls. Experience with laboratory equipment qualification, calibration, and validation activities. Experience supporting internal audits, regulatory inspections, and quality compliance programs. Relevant industry certifications are a plus. Work Environment & Physical Requirements Primarily office-based with regular interaction and oversight within Quality Control laboratory and manufacturing environments. Frequent sitting, standing, walking, and computer use; occa