Sterilization QA Associate I — Ensure Quality & Compliance

RXinsider LTD.; Irvine, Northern (CA, KY); Hybrid; USD 33,000 - 39,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization operations in a GMP manufacturing setting. You will review records, data, and documentation to ensure regulatory compliance and data integrity, partnering with cross-functional teams to support product releases.

The role requires a detail-oriented individual with experience in regulated environments and familiarity with electronic systems used for batch review and release.

Qualifications

• The candidate has a high school diploma or GED and experience in regulated environments.
• Experience reviewing documentation for accuracy and regulatory compliance.
• Working knowledge of GMPs, GDP, and quality systems.
• Proficiency with Microsoft Office and electronic quality systems.

Responsibilities

• Review sterilization records, batch documentation, and quality records for accuracy and compliance.
• Utilize LIMS, MES, Wonderware, and EBR systems to support review and product release.
• Identify deviations, nonconformances, and documentation discrepancies per procedures.
• Support sterilization batch disposition and release decisions through thorough review.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities to resolve issues.
• Maintain audit-ready records and support regulatory and quality system requirements.
• Contribute to continuous improvement initiatives in quality and operations.

Skills

Attention to detail

Communication skills

Problem solving

Microsoft Office

Education

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

Tools

LIMS

MES

Wonderware

Electronic Batch Records (EBR)

Job description

B. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization operations in a GMP manufacturing setting. You will review records, data, and documentation to ensure regulatory compliance and data integrity, partnering with cross-functional teams to support product releases.

The role requires a detail-oriented individual with experience in regulated environments and familiarity with electronic systems used for batch review and release.