QC Microbiology Assoc ; Sun-Tues​/Wed

B. Braun Medical, Inc.

Company: B. Braun US Pharmaceutical Manufacturing LLC

Job Posting

Location:

Irvine, California, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Wednesday, Tuesday, Monday, Sunday

Shift: 3/4 X 12

Relocation Available: No

B. 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

The QC Microbiology Associate performs routine microbiological testing and laboratory support activities to ensure the safety, quality, and compliance of

B. Braun products and manufacturing processes. This role supports environmental monitoring, microbial testing of finished products, utilities, raw materials, and stability samples in accordance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements. Working in a laboratory environment, the QC Microbiology Associate is responsible for generating accurate test results, maintaining laboratory equipment, and supporting continuous improvement initiatives within the Quality Control Microbiology department.

This position is onsite and collaborates closely with Quality, Manufacturing, and Technical Services teams to support product quality and patient safety.

• Perform microbiological testing, including sample receipt, preparation, incubation, enumeration, identification, and documentation of test results for finished products, stability studies, utilities, environmental monitoring, and other assigned samples.
• Accurately record, review, and maintain laboratory data and documentation in compliance with cGMP requirements, laboratory procedures, and data integrity standards.
• Support laboratory operations by maintaining equipment, media, reagents, and supplies to ensure uninterrupted testing activities.
• Assist with equipment qualification, calibration, preventive maintenance, troubleshooting, and performance monitoring activities.
• Review test results for compliance with specifications, procedures, and regulatory requirements and promptly elevate atypical findings.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), and laboratory deviations as assigned.
• Participate in the revision and improvement of laboratory procedures, test methods, and standard operating procedures (SOPs) to support continuous improvement initiatives.

• High School Diploma or GED required;
  Associate degree in Microbiology, Biology, Biotechnology, or a related scientific discipline preferred.
• 0-2 years of experience in a microbiology, laboratory, pharmaceutical, medical device, biotechnology, or related regulated environment.
• Basic knowledge of microbiological techniques, aseptic practices, and laboratory safety procedures.
• Ability to follow written procedures and accurately document laboratory activities.
• Strong attention to detail and organizational skills with the ability to manage multiple priorities.
• Basic computer proficiency, including Microsoft Office applications.
• Ability to work in a team-oriented environment while maintaining compliance with quality and safety requirements.

• Experience working in a cGMP-regulated pharmaceutical, medical device, or biotechnology environment.
• Hands-on experience with environmental monitoring, bioburden testing, microbial identification, or sterility testing.
• Familiarity with laboratory systems, data management software, and electronic documentation practices.
• Knowledge of USP microbiological testing requirements and contamination control principles.

• Assignments are routine and performed according to…