Quality Specialist I

B. Braun US Pharmaceutical Manufacturing LLC

Irvine, CA

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JOB DETAILS

SALARY

$90,000–$107,000 Per Year

SKILLS

Best Practices, Business Solutions, Calibration, Continuous Improvement, Cost Control, Cross-Functional, Data Quality, Detail Oriented, Dialysis, Documentation Review, Drug Manufacturing, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Healthcare, ICH Regulations, Intravenous Therapies, Laboratory Information Management System (LIMS), Lift/Move 20 Pounds, Maintain Compliance, Manufacturing, Manufacturing Operations, Medical Products, Metadata, Nutrition, Operational Support, Ostomy, Pain Management, Pharmacy, Philosophy, Problem Solving Skills, Product Reviews, Product Support, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Safety Standards, Safety/Work Safety, Software Validation, Spreadsheets, Standard Operating Procedures (SOP), Support Documentation, Systems Maintenance, Wound Care

LOCATION

Irvine, CA

POSTED

1 day ago

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, Thursday, Friday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 11786 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 Quality Specialist I provides hands-on quality support to manufacturing operations, ensuring products meet regulatory, safety, and quality standards. This role is responsible for reviewing documentation, supporting investigations, and maintaining compliance with internal quality systems and industry requirements. Primary duties include completing batch record reviews (both electronic and paper-based) to support manufacturing and product release activities. Key Responsibilities Complete batch record reviews (electronic and paper) to support manufacturing operations and product release Review SOPs, protocols, reports, and batch records for accuracy and compliance Review data (including metadata) to ensure accuracy, completeness, and data integrity Support deviations (NCs), investigations, and CAPAs, including review of reports in systems such as TrackWise Ensure compliance with FDA, ICH, and internal quality standards Provide oversight for equipment and software qualification, validation, and calibration activities Utilize and maintain data within systems such as LIMS, ERP, and spreadsheets to support quality processes Partner with quality and cross-functional teams to maintain compliance and standardized processes Qualifications Bachelor’s degree or equivalent experience in a related field 4 years of experience in quality, manufacturing, or a regulated environment Experience with quality and business systems such as TrackWise (NCs), LIMS, ERP systems, and spreadsheets Understanding of GMP/regulatory requirements and data integrity principles preferred Strong attention to detail and problem-solving skills Ability to work independently and manage priorities Work Environment Primarily office-based with some time in a manufacturing environment Moderate noise levels in production areas Regular sitting, standing, and use of hands Ability to lift up to 20 lbs occasionally Pay Rate- $90,000- $107,000 annually 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. Compensation details: 90000-107000 Yearly Salary PI6426e9d61f07-25448-406360315c143e31-5e48-4549-b638-05792d185386

About the Company

B. Braun US Pharmaceutical Manufacturing LLC

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