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Quality Specialist I
- Irvine, California, United States
- Irvine, California, United States
Über
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: 10952
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 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
- 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- $87,000-107,000
The targeted range for this role takes into
Sprachkenntnisse
- English
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