Sterility QA Associate - GMP Review & Release

B. Braun Medical Inc. (US); Irvine (CA); On-site; USD 68,770,000 - 80,231,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. seeks a QA Associate, Sterilization Assurance to oversee sterilization and release activities in a GMP environment. The role reviews records to ensure GMP, GDP, and data integrity compliance, and collaborates across Manufacturing, Engineering, and Quality teams to resolve quality issues.

The position emphasizes documenting and tracing information for product disposition, with opportunities for continuous improvement and audit readiness.

Qualifications

• High School Diploma or GED required.
• Experience in GMP, GDP, and data integrity.
• Ability to review documentation for accuracy and completeness.

Responsibilities

• Review sterilization records, batch documentation, and quality records for accuracy and compliance.
• Utilize LIMS, MES, Wonderware, and EBRs to support release activities.
• Identify deviations, nonconformances, and documentation discrepancies.
• Verify sterilization documentation and traceability for product release decisions.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities to resolve issues.
• Support product disposition and release activities with audit-ready records.
• Participate in continuous improvement initiatives.

Skills

GMPs

GDP

Data integrity

Documentation review

Cross-functional collaboration

Microsoft Office

Education

HS diploma or GED

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

Tools

LIMS

MES

Wonderware

Electronic Batch Records

Job description

B. Braun Medical Inc. seeks a QA Associate, Sterilization Assurance to oversee sterilization and release activities in a GMP environment. The role reviews records to ensure GMP, GDP, and data integrity compliance, and collaborates across Manufacturing, Engineering, and Quality teams to resolve quality issues.

The position emphasizes documenting and tracing information for product disposition, with opportunities for continuous improvement and audit readiness.