Quality Specialist II

B. Braun US Pharmaceutical Manufacturing LLC

Irvine, CA

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JOB DETAILS

SALARY

$96,000–$118,000 Per Year

SKILLS

Best Practices, Calibration, Communication Skills, Continuous Improvement, Cost Control, Data Quality, Dialysis, Documentation Review, Drug Manufacturing, FDA (Food and Drug Administration), Healthcare, ICH Regulations, Intravenous Therapies, Lift/Move 20 Pounds, Maintain Compliance, Manufacturing, Medical Products, Multitasking, Nutrition, Organizational Skills, Ostomy, Pain Management, Pharmacy, Philosophy, Physical Demands, Problem Solving Skills, Process Manufacturing, Product Safety, Product Support, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Safety/Work Safety, Standard Operating Procedures (SOP), Support Documentation, Time Management, 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: Friday, Thursday, Wednesday, Tuesday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 12095 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 II provides oversight of the Quality System to ensure compliance with regulatory standards and internal procedures. This role supports product quality and safety by reviewing documentation, data, and processes related to manufacturing, testing, and distribution, while driving adherence to industry regulations and continuous improvement. Key Responsibilities Provide Quality oversight of the Quality System, including review of SOPs, protocols, reports, and manufacturing records. Perform timely review of data and documentation supporting batch release. Ensure compliance with FDA, ICH, and internal quality standards. Review records to ensure data integrity and accuracy. Support and approve investigations, including review of reports. Oversee equipment and software qualification, calibration, and validation activities. Collaborate with Corporate Quality to implement standardized processes and ensure compliance. Perform additional duties as assigned. Qualifications Bachelor’s degree or equivalent combination of education and experience required. A minimum of 6 years of experience in a regulated industry. Strong knowledge of quality systems, regulatory requirements, and data integrity principles. Excellent problem-solving, organizational, and communication skills. Ability to work independently with general supervision and manage multiple priorities. Relevant industry certification preferred. Work Environment & Physical Requirements Primarily office-based with occasional exposure to manufacturing environments. Light physical activity (sitting, standing, and occasional lifting up to 20 lbs). Moderate noise level. Salary Range- $96,000-$118,000/ 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: 96000-118000 Yearly Salary PI9ede5012fe66-25448-407939005c143e31-5e48-4549-b638-05792d185386

About the Company

B. Braun US Pharmaceutical Manufacturing LLC

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