Quality Specialist

B. Braun US Pharmaceutical Manufacturing LLC – Irvine, California – On‑site

The Quality Specialist I provides hands‑on quality support to manufacturing operations, ensuring products meet regulatory, safety, and quality standards. This role reviews documentation, supports investigations, and maintains compliance with internal quality systems and industry requirements.

• Complete batch record reviews (both electronic and paper‑based) to support manufacturing and product release activities.
• 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 Track Wise.
• 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.

• 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 Track Wise (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

Benefits include healthcare, a 401(k) plan, and tuition reimbursement.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, veteran status, marital status, or any other legally protected status.

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