Quality Specialist I
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: 12096
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
Key Responsibilities
Review and approve SOPs, protocols, reports, and manufacturing data (including metadata)
Perform timely Quality review of data supporting batch release
Ensure compliance with FDA, ICH, and internal Quality System requirements
Support regulatory compliance related to product safety and quality
Review records to ensure data integrity and industry compliance
Provide Quality oversight for investigations, including review and approval of reports
Oversee equipment and software qualification, calibration, and validation activities
Partner with Corporate Quality to implement standardized processes and ensure compliance
Support audit readiness activities, including preparation and inspection support
Follow up with cross-functional teams on audit responses and corrective actions
Maintain and update the Site Master File and regulatory certifications
Qualifications
Bachelor’s degree required
A minimum of 4 years of regulatory experience
Industry certification preferred
Skills & Experience
Working knowledge of quality systems and regulatory requirements
Strong attention to detail and organizational skills
Ability to manage priorities and solve routine issues independently
Additional Information
Primarily office-based with occasional manufacturing environment exposure
Ability to perform light physical tasks (up to 20 lbs)
Regular and predictable attendance required
Salary Range- $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 .
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, .
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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