QA Associate I, Sterilization Assurance in Irvine, California at B. Braun US Pharmaceutical Manufacturing LLC

B. Braun Medical, Inc.
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

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 is responsible for reviewing sterilization records, electronic 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, Quality, and other cross-functional teams to support product release activities, identification of quality events, and resolution of documentation discrepancies.

The ideal candidate will have experience in quality, manufacturing, laboratory, or other regulated environments and possess strong attention to detail, analytical skills, and a commitment to ensuring product quality and patient safety.

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 record review and product release activities.
• Identify, document, and escalate deviations, nonconformances, and documentation discrepancies in accordance with established procedures.
• Support sterilization batch disposition and product release decisions through thorough review of quality and manufacturing records.
• Collaborate with Manufacturing, Quality, Engineering, and Facilities teams to resolve documentation and process-related issues.
• Maintain audit-ready records and support compliance with regulatory and quality system requirements.
• Contribute to continuous improvement initiatives that enhance quality, compliance, and operational effectiveness.

Essential Requirements

• High School Diploma or GED required.
• Minimum 1 year of experience supporting sterilization, quality assurance, manufacturing, or validation activities.
• 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 communication, organizational, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work non-standard hours as business needs require.

Preferred Qualifications

• Associate or Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Sciences, Engineering, Quality Management, or related scientific discipline.
• Familiarity with deviation investigations, CAPA, nonconformance management, and product release processes.
• Experience working with LIMS, MES, Wonderware, Electronic Batch Records (EBR) to generate process, and review Sterilizer Load Reports (SLRs), including deviated and non-conforming batches.
• Knowledge of sterilization processes and validation principles.

Physical Demands & Work Environment

• Ability to sit, stand, walk, and perform computer-based work for extended periods.
• Ability to lift up to 20 pounds occasionally.
• Requires visual acuity and attention to detail for reviewing quality documentation and electronic records.
• Work is performed in office, laboratory, and GMP-regulated manufacturing environments.
• Regular interaction with production operations and manufacturing equipment in support of quality assurance activities.

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.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.