QAO Chemistry Specialist II in Irvine, California at B. Braun US Pharmaceutical Manufacturing LLC
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Job Description
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
Requisition ID: 12095
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
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.
In This Role, You Will Have the Chance To:
- 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, LabWare LIMS, SAP, and TrackWise 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.
Essential Requirements
- 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 LabWare LIMS, SAP (ERP), TrackWise, and Empower Chromatography Data System.
- Strong knowledge of GMPs, FDA regulations, ICH guidelines, and data integrity principles.
- Excellent problem-solving, organizational, and communication skills.
Preferred Experience Includes
- 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 industry certifications are a plus.
Work Environment & Physical Requirements
- Primarily office-based with regular interaction and oversight within Quality Control laboratory and manufacturing environments.
- Frequent sitting, standing, walking, and computer use; occasional lifting of materials up to 20 lbs.
- Ability to review analytical data, chromatograms, and electronic records for accuracy and compliance.
- Exposure to moderate noise levels in office, laboratory, and manufacturing environments.
Salary Range- $96,000-$118,000/ annually
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.