QA Associate I, Sterilization Assurance

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

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Company: B. Braun US Pharmaceutical Manufacturing LLC

Job Posting Location: Irvine, California, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday

Shift: 5X8

Relocation Available: No

Requisition ID: 14034

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position 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 is responsible for reviewing sterilization records, batch documentation, and quality system records to ensure compliance with regulatory requirements, Good Documentation Practices (GDP), and data integrity standards. The QA Associate partners closely with Manufacturing, Engineering, Facilities, and Quality teams to support product disposition, release activities, and resolution of quality events.

In This Role, You Will Have the Chance To:

• 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.

High School Diploma or GED required.

Minimum one (1) 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.

Preferred Qualifications

• Associate or Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Sciences, Engineering, Quality Management, or a related scientific discipline.
• Experience working in pharmaceutical, medical device, biotechnology, or other regulated manufacturing environments.
• Familiarity with sterilization processes, validation principles, CAPA, deviation investigations, and nonconformance management.
• Experience with LIMS, MES, Wonderware, Electronic Batch Records, or similar quality systems.
• Knowledge of FDA regulations, including 21 CFR Part 11 and cGMP requirements.

Knowledge & Skills

• Ability to interpret procedures, specifications, and quality documentation.
• Strong written and verbal communication skills with the ability to collaborate cross-functionally.
• Ability to manage multiple priorities in a fast-paced environment.
• Sound judgment in identifying, escalating, and resolving quality-related issues.
• Commitment to quality, compliance, and continuous improvement.

Physical Demands & Work Environment

Ability to sit, stand, walk, and perform computer-based work throughout the workday.

Ability to lift up to 20 pounds occasionally.

Requires visual acuity and attention to detail for review of electronic and paper records.

Work is performed in office, laboratory, and GMP-regulated manufacturing environments.

Regular interaction with production operations and manufacturing equipment.

Moderate noise levels may be present in manufacturing areas.

Pay Range- $24.00 - $28.00/hour

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com .

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .