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: 12925 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. Key Responsibilities - Review SOPs, protocols, reports, and batch records to support manufacturing and product release - Review data (including metadata) to ensure accuracy, completeness, and data integrity - Support deviations, investigations, and CAPAs, including review of reports - Ensure compliance with FDA, ICH, and internal quality standards - Provide oversight for equipment and software qualification, validation, and calibration activities - 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 - 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 Schedule: Onsite M-F 8am to 5pm 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.