QA Associate, Sterilization Assurance — Onsite

B. Braun Melsungen AG; Irvine (CA); On-site; USD 33,000 - 39,000; Full time

Job summary

B. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization and product release within a GMP-regulated manufacturing environment.

This role ensures compliance and accurate documentation across records, systems and release decisions. You will review sterilization records, collaborate with Manufacturing, Quality, Engineering and Facilities to resolve issues and maintain audit-ready records.

Qualifications

• High School Diploma or GED required.
• Minimum one year of experience in manufacturing, quality, laboratory, or FDA-regulated environments.
• Experience reviewing documentation for accuracy, completeness, and compliance.
• Working knowledge of GMPs, GDP, and quality system requirements.
• Strong attention to detail and commitment to data integrity.
• Proficiency with Microsoft Office and electronic quality systems.
• Strong organizational, analytical, and problem-solving skills.
• Ability to work non-standard hours as business needs require.
• Regular and predictable onsite attendance required.

Responsibilities

• Review sterilization records, batch documentation, and quality records for accuracy, completeness, and compliance with GMP, GDP, and data integrity requirements.
• Utilize electronic systems including LIMS, MES, Wonderware, and Electronic Batch Records (EBR) to support sterilization review and release activities.
• Identify, document, and elevate deviations, nonconformances, and documentation discrepancies in accordance with established procedures.
• Verify sterilization documentation and traceability records to support product release decisions.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities teams to resolve quality and documentation issues.
• Support product disposition and release activities while maintaining audit-ready records.
• Participate in continuous improvement initiatives to enhance compliance and operational efficiency.

Skills

Attention to detail

Communication skills

Analytical skills

Problem solving

Education

High School Diploma or GED

Bachelor's degree related science

Tools

LIMS

MES

Wonderware

Electronic Batch Records

Job description

B. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization and product release within a GMP-regulated manufacturing environment.

This role ensures compliance and accurate documentation across records, systems and release decisions. You will review sterilization records, collaborate with Manufacturing, Quality, Engineering and Facilities to resolve issues and maintain audit-ready records.