QC Microbiology Assoc I (Wed/Thurs-Sat 6:00pm-6:00am)

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); Vor Ort; USD 33.000 - 39.000; Vollzeit

Benefits dieser Stelle

Healthcare benefits

401(k) plan

Tuition reimbursement

Zusammenfassung

B. Braun Medical Inc. in Irvine, California, is seeking a QC Microbiology Associate to join the Onsite Quality team.

The role supports environmental monitoring, microbial testing of finished products, utilities, raw materials, and stability samples under cGMP guidelines. You will generate accurate test results, maintain lab equipment, and contribute to continuous improvement. A high school diploma is required with a preference for an Associate degree in a related micro/biotech field, and

Qualifikationen

• High School Diploma or GED; Associate degree in Microbiology, Biology, Biotechnology, or related field preferred.
• 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.

Aufgaben

• 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.

Kenntnisse

Microbiology techniques

Aseptic practices

Laboratory safety

Documentation

Procedural compliance

Team collaboration

Data entry

Microsoft Office

cGMP awareness

Regulatory compliance

Ausbildung

Associate degree in Microbiology, Biology, Biotechnology, or related

Tools

Laboratory equipment

Electronic documentation

Data management software

Jobbeschreibung

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: Saturday, Friday, Thursday, Wednesday

Shift: 3/4 X 12

Relocation Available: No

Requisition ID: 14568

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 www.bbraunusa.com

Position Summary

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.

In This Role, You Will Have the Chance To:

• 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.

Essential Requirements

• High School Diploma or GED required; Associate degree in Microbiology, Biology, Biotechnology, or a related scientific discipline preferred.
• 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.

Preferred Experience Includes

• 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.

Expertise: Knowledge & Skills

• Assignments are routine and performed according to established laboratory procedures and work instructions.
• Works under direct supervision with increasing independence as proficiency is demonstrated.
• Uses established methods to perform testing and complete assigned tasks.
• Exercises limited judgment in resolving routine laboratory issues and escalating concerns appropriately.
• Regular interaction with supervisors, peers, Quality, and Manufacturing personnel.

Compensation

$23.68 -$28.37/ hour

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Equal employment opportunity, including veterans and individuals with disabilities.

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