QA Associate I - Sterilization Compliance (Onsite)

B. Braun US Pharmaceutical Manufacturing LLC; 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 operations within a GMP-regulated manufacturing environment.

This role reviews sterilization records, electronic batch documentation, and quality system records to ensure compliance with regulatory requirements and GDP standards. The ideal candidate will have experience in quality, manufacturing, or regulated environments, with strong attention to detail and data integrity, and

Qualifications

• High School Diploma or GED required.
• Minimum 1 year of experience in sterilization, QA, manufacturing, or validation.
• Experience reviewing documentation for accuracy 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.

Responsibilities

• Review sterilization records, batch documentation, and quality records for accuracy and compliance with GMP and GDP.
• Utilize LIMS, MES, Wonderware, and EBR to support sterilization record review and product release.
• Identify, document, and escalate deviations and nonconformances.
• Support sterilization batch disposition and product release decisions.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities teams to resolve documentation and process issues.
• Maintain audit-ready records and support regulatory and quality system requirements.
• Contribute to continuous improvement initiatives to enhance quality and operational effectiveness.

Skills

GMP/GDP knowledge

Quality systems

Documentation review

Attention to detail

MS Office

Electronic systems

Education

High School Diploma or GED

Associate or Bachelor's degree (preferred)

Tools

LIMS

MES

Wonderware

Electronic Batch Records (EBR)

Microsoft Office

Job description

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

This role reviews sterilization records, electronic batch documentation, and quality system records to ensure compliance with regulatory requirements and GDP standards. The ideal candidate will have experience in quality, manufacturing, or regulated environments, with strong attention to detail and data integrity, and