QA Associate, Sterilization Assurance — Onsite

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

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

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

This role reviews sterilization records, batch documentation, and quality system records to ensure regulatory compliance and data integrity. You will collaborate with Manufacturing, Engineering, Facilities, and Quality teams to resolve quality events and support disposition while maintaining

Qualifications

• Minimum one year of experience in manufacturing, quality, laboratory, or FDA-regulated environments.
• Strong knowledge of GMPs, GDP, and data integrity requirements.
• Proficiency with Microsoft Office and electronic quality systems.
• Attention to detail and ability to maintain audit-ready records.

Responsibilities

• Review sterilization records, batch documentation, and quality records for accuracy and compliance.
• Utilize systems like LIMS, MES, Wonderware, and EBR to support sterilization review and release.
• Identify and escalate deviations, nonconformances, and documentation discrepancies.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities to resolve issues.
• Support product disposition and maintain audit-ready records.
• Participate in continuous improvement initiatives to enhance compliance and efficiency.

Skills

GMPs

GDP

Quality systems

Microsoft Office

Electronic quality systems

LIMS

MES

Wonderware

EBR

Documentation review

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Sciences, Engineering, Quality Management, or related

Associate degree in related field

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 activities within a GMP-regulated manufacturing environment.

This role reviews sterilization records, batch documentation, and quality system records to ensure regulatory compliance and data integrity. You will collaborate with Manufacturing, Engineering, Facilities, and Quality teams to resolve quality events and support disposition while maintaining