Quality Specialist I — GMP & Data Integrity, Irvine

NCSL International; Irvine, Northern (CA, KY); Hybrid; USD 90,000 - 107,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, California is seeking a Quality Specialist I to provide hands-on quality support for manufacturing operations and ensure regulatory, safety, and quality standards are met.

The role involves reviewing documentation, supporting investigations, and maintaining compliance with internal quality systems and industry requirements. On-site work with cross-functional collaboration is expected.

Qualifications

• Bachelor's degree or equivalent experience in a related field.
• 4+ years of experience in quality, manufacturing, or a regulated environment.
• Understanding of GMP/regulatory requirements and data integrity principles preferred.
• Strong attention to detail and problem-solving skills.
• Ability to work independently and manage priorities.

Responsibilities

• Review SOPs, protocols, reports, and batch records to support manufacturing and product release.
• Review data to ensure accuracy, completeness, and data integrity.
• Support deviations, investigations, and CAPAs, including review of reports.
• Ensure compliance with FDA, ICH, and internal quality standards.
• Provide oversight for equipment and software qualification, validation, and calibration activities.
• Partner with quality and cross-functional teams to maintain compliance and standardized processes.

Skills

Attention to detail

Problem-solving

Independent work

Education

Bachelor's degree

Job description

B. Braun US Pharmaceutical Manufacturing LLC in Irvine, California is seeking a Quality Specialist I to provide hands-on quality support for manufacturing operations and ensure regulatory, safety, and quality standards are met.

The role involves reviewing documentation, supporting investigations, and maintaining compliance with internal quality systems and industry requirements. On-site work with cross-functional collaboration is expected.