QC Microbiology Assoc II (Sun-Thurs 7:00am-3:30pm)

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); On-site; USD 36,000 - 45,000; Full time

Job summary

B. Braun Medical Inc. is seeking a Microbiology II professional to support microbiological testing and monitoring within a GMP-regulated pharmaceutical manufacturing environment in Irvine, CA.

This onsite role collaborates with Quality, Manufacturing, and Laboratory teams to ensure compliance with cGMP, GLP, USP, and FDA requirements. Responsibilities include routine testing of raw materials and finished products, document data in LIMS, and participate in investigations and continuous

Qualifications

• Bachelor's degree in Microbiology or related field.
• 1-2 years of related lab experience if degree obtained.
• Experience in GMP/GLP regulated environment.

Responsibilities

• Perform routine microbiological testing of raw materials and finished products.
• Maintain laboratory records, logbooks, and LIMS entries in compliance with ALCOA, GDP, and data integrity requirements.
• Support investigations and non-routine testing and continuous improvement activities.
• Ensure compliance with cGMP, GLP, SOPs, USP standards, and FDA regulations.

Skills

Microbiology testing

Aseptic techniques

Data analysis

Documentation

Education

Bachelor's in Microbiology

Tools

LIMS

Microsoft Office

Job description

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: Thursday, Wednesday, Tuesday, Monday, Sunday

Shift: 5X8

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 www.bbraunusa.com.

Position Summary

B. 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 Requirements

• High 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 Includes

• Bachelor'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 Environment

• Ability to sit, stand, walk, bend, and perform repetitive laboratory tasks throughout the workday.
• Ability to lift up to 20 pounds occasionally.
• Requires visual acuity and manual dexterity for laboratory testing and documentation activities.
• Work is performed in a laboratory and GMP-regulated manufacturing environment.
• Must be able to follow laboratory safety procedures and wear required PPE.
• Moderate noise level and regular interaction with laboratory equipment and testing materials.

Pay Range- $25.70 - $33.00/ 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.