QAO Chemistry Specialist II

RXinsider LTD.; Irvine (CA); On-site; USD 96,000 - 118,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a Quality Specialist II to provide oversight of the Quality System and ensure compliance with FDA, ICH, and internal standards. You will review documentation, data, and manufacturing records to support product quality and safety.

The role requires a bachelor's degree with at least six years in a regulated industry, strong problem-solving, communication, and the ability to work independently with minimal supervision.

Qualifications

• Bachelor's degree or equivalent combination of education and experience required.
• A minimum of 6 years of experience in a regulated industry.
• Strong knowledge of quality systems, regulatory requirements, and data integrity principles.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work independently with general supervision and manage multiple priorities.
• Relevant industry certification preferred.

Responsibilities

• Provide Quality oversight of the Quality System, including review of SOPs, protocols, reports, and manufacturing records.
• Perform timely review of data and documentation supporting batch release.
• Ensure compliance with FDA, ICH, and internal quality standards.
• Review records to ensure data integrity and accuracy.
• Support and approve investigations, including review of reports.
• Oversee equipment and software qualification, calibration, and validation activities.
• Collaborate with Corporate Quality to implement standardized processes and ensure compliance.
• Perform additional duties as assigned.

Skills

Quality systems knowledge

Regulatory knowledge

Data integrity principles

Problem-solving

Organizational skills

Communication skills

Independent work

Education

Bachelor's degree or equivalent

Job description

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 Quality Specialist II provides oversight of the Quality System to ensure compliance with regulatory standards and internal procedures. This role supports product quality and safety by reviewing documentation, data, and processes related to manufacturing, testing, and distribution, while driving adherence to industry regulations and continuous improvement.

Key Responsibilities

• Provide Quality oversight of the Quality System, including review of SOPs, protocols, reports, and manufacturing records.
• Perform timely review of data and documentation supporting batch release.
• Ensure compliance with FDA, ICH, and internal quality standards.
• Review records to ensure data integrity and accuracy.
• Support and approve investigations, including review of reports.
• Oversee equipment and software qualification, calibration, and validation activities.
• Collaborate with Corporate Quality to implement standardized processes and ensure compliance.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree or equivalent combination of education and experience required.
• A minimum of 6 years of experience in a regulated industry.
• Strong knowledge of quality systems, regulatory requirements, and data integrity principles.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work independently with general supervision and manage multiple priorities.
• Relevant industry certification preferred.

Work Environment & Physical Requirements

• Primarily office-based with occasional exposure to manufacturing environments.
• Light physical activity (sitting, standing, and occasional lifting up to 20 lbs).
• Moderate noise level.

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.