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: 11786
Position SummaryThe 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
