Quality Control Analyst

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 Requisition ID: 13451 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 Position Summary The QC Microbiology Associate II performs microbiological testing and laboratory support activities to ensure compliance with current Good Manufacturing Practices (cGMP), company procedures, and quality standards. This position is responsible for the receipt, preparation, testing, documentation, and review of microbiological samples and results. The Associate II supports laboratory operations through equipment maintenance activities, data integrity practices, and adherence to established quality systems. The role requires a strong attention to detail, the ability to work in a regulated laboratory environment, and a commitment to maintaining safe and efficient laboratory operations. This position reports to the QC Microbiology Supervisor/Manager and is based onsite. In This Role, You Will Have the Chance To: Perform microbiological testing on finished products, stability samples, environmental monitoring samples, and other laboratory samples in accordance with approved procedures and test methods. Receive, prepare, process, and document samples while maintaining data integrity and compliance with cGMP requirements. Record, review, and compile laboratory results, reports, and supporting documentation to ensure accuracy, completeness, and compliance with established specifications. Support laboratory equipment calibration, qualification, preventive maintenance, troubleshooting, and routine operational activities. Verify test results and ensure compliance with approved procedures, methods, specifications, and quality standards. Assist with the development, revision, and continuous improvement of laboratory procedures, test methods, and documentation practices. Maintain laboratory cleanliness, organization, and compliance with all applicable safety, quality, and regulatory requirements. Essential Requirements High School Diploma or GED required. Minimum one (1) year of laboratory, microbiology, quality control, or related scientific experience. Strong attention to detail with excellent documentation and recordkeeping skills. Ability to follow written procedures and work effectively within a regulated environment. Proficient in data recording, report preparation, and review of laboratory documentation. Ability to work independently and collaboratively within a team environment. Flexibility to work non-standard hours as business needs require. Preferred Experience Includes Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline. Experience working in a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment. Familiarity with cGMP regulations, laboratory quality systems, and microbiological testing methods. Experience supporting laboratory investigations, equipment qualification, or continuous improvement initiatives. Physical & Work Environment Laboratory-based role requiring frequent standing, walking, bending, and use of laboratory equipment. Ability to lift and carry up to 20 pounds occasionally. Moderate noise levels typical of a laboratory and manufacturing support environment. Required use of appropriate personal protective equipment (PPE) and adherence to all safety procedures. May involve exposure to biological materials, laboratory reagents, and controlled environmental conditions consistent with microbiology laboratory operations. 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 . 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. PI71be962ec367-37344-41301304