QAO Chemistry Specialist II

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.

QAO Chemistry Specialist II

Company:

B. Braun US Pharmaceutical Manufacturing LLC

Job Posting

Location:

Irvine, California, United States

Functional Area:

Quality

Working Model:
Onsite

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

Shift: 5X8

Relocation Available:
No

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

The QAO Chemistry Specialist II provides Quality Assurance oversight of Quality Control laboratory operations and quality systems to ensure compliance with regulatory requirements and internal standards. This role is responsible for reviewing analytical testing data, laboratory records, and quality documentation supporting product release activities while ensuring data integrity and GMP compliance. The ideal candidate will have a strong QA/QC Chemistry background with expertise in analytical techniques including HPLC, UPLC, GC, FTIR, and Wet Chemistry.

This position partners closely with Quality Control, Manufacturing, and Corporate Quality teams to support investigations, compliance initiatives, and continuous improvement efforts.

• Provide Quality Assurance oversight of Quality Control laboratory operations and quality systems to ensure GMP and regulatory compliance.
• Review and approve analytical data, laboratory documentation, protocols, reports, and records supporting product release activities.
• Review testing data generated using HPLC, UPLC, GC, FTIR, and Wet Chemistry methods to ensure accuracy, compliance, and data integrity.
• Utilize Empower, Lab Ware LIMS, SAP, and Track Wise to support data review, investigations, and quality processes.
• Support and approve deviations, investigations, OOS/OOT events, CAPAs, change controls, and validation activities while driving continuous improvement initiatives.
• Bachelor's degree or equivalent combination of education and experience required.
• Minimum of 6 years of experience, preferably within pharmaceutical, biotechnology, medical device, or related manufacturing environments.
• Strong Quality Assurance and/or Quality Control Chemistry background with experience reviewing analytical data and laboratory records.
• Comprehensive knowledge of HPLC, UPLC, GC, FTIR, and Wet Chemistry methodologies.
• Experience with Lab Ware LIMS, SAP (ERP), Track Wise, and Empower Chromatography Data System.
• Strong knowledge of GMPs, FDA regulations, ICH guidelines, and data integrity principles.
• Excellent problem-solving, organizational, and communication skills.

• Experience supporting laboratory investigations, deviations, CAPAs, and change controls.
• Experience with laboratory equipment qualification, calibration, and validation activities.
• Experience supporting internal audits, regulatory inspections, and quality compliance programs.
• Relevant…