B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Thursday, Wednesday, Tuesday, Monday, SundayShift: 5X8Relocation Available: NoRequisition ID: 13715B. 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 Microbiology II professional to support microbiological testing and monitoring activities within a GMP-regulated pharmaceutical manufacturing environment. This role is responsible for routine microbiological testing of raw materials, finished products, stability samples, and environmental monitoring programs while ensuring compliance with cGMP, GLP, USP, and FDA requirements. The Microbiology II position plays a key role in maintaining laboratory quality standards, supporting data integrity initiatives, and contributing to investigations and continuous improvement efforts. This position is onsite and collaborates closely with Quality, Manufacturing, and Laboratory teams. In This Role, You Will Have the Chance To:Perform routine microbiological testing and monitoring of raw materials, finished products, stability samples, and related laboratory programs.Utilize aseptic techniques while conducting microbiological testing and analysis.Collect, analyze, trend, and document microbiological data to support product quality and compliance.Maintain accurate laboratory records, logbooks, data sheets, and LIMS entries in accordance with ALCOA, GDP, and data integrity requirements.Support laboratory operations through preparation of media, reagents, testing materials, and equipment as needed.Participate in investigations, non-routine testing, and continuous improvement activities.Ensure compliance with cGMPs, GLPs, SOPs, USP standards, and FDA regulations. Essential RequirementsHigh School Diploma or equivalent required.With a Bachelor's degree in Microbiology or a related scientific discipline: 1-2 years of related laboratory experience preferred.Without a four-year degree: 3-5 years of microbiology, laboratory, or quality-related experience required.Experience working in a GMP, GLP, pharmaceutical, medical device, or other regulated environment.Working knowledge of microbiological testing methods and aseptic laboratory practices.Experience using Microsoft Office applications and laboratory data management systems.Strong organizational skills, attention to detail, and written/verbal communication skills. Preferred Experience IncludesBachelor's degree in Microbiology, Biology, or related scientific field.Experience with bioburden, endotoxin (LAL), environmental monitoring, and microbial identification testing.Experience working with LIMS or other electronic laboratory systems.Knowledge of FDA, USP, cGMP, and GLP regulations.Experience supporting investigations, deviation reviews, and non-conformance activities. Physical Demands & Work EnvironmentAbility to sit, stand, walk, bend, and perform repetitive laboratory tasks throughout the workday.Ability to lift up to 20 pounds occasionally.Req
Not specified in the original listing.
Not specified in the original listing.