Quality Lead I: GMP Release & Incident Oversight

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical, Inc. in Irvine, CA is seeking a Quality Lead I to provide quality oversight for GMP manufacturing operations, ensuring timely QCRVs and IR handling, and coordinating cross‑functional activities to keep production ready.

The role requires strong knowledge of GMP, documentation practices, and quality systems, with the ability to train Quality Operations Associates and escalate issues to Quality Management. Regular on‑site attendance is required.

Qualifications

• Bachelor’s degree in science, engineering, or related field preferred, or six years in GMP‑regulated environment.
• Experience managing Quality Control Release Verifications (QCRVs) and Incident Reports (IRs).
• Strong understanding of GMP regulations and documentation practices.
• Ability to interpret procedures and conduct investigations across functional areas.
• On‑site attendance required with non‑standard schedules as needed.

Responsibilities

• Perform Quality Control Release Verifications (QCRVs) and process Incident Reports (IRs) to support manufacturing while ensuring GMP compliance.
• Manage QCRV and IR workflows to ensure laboratory testing requirements are identified and completed before room release.
• Review manufacturing docs and quality records to verify completion prior to authorizing release.
• Interpret quality procedures and manufacturing requirements while ensuring regulatory expectations.
• Assist with investigations, gather information, and support corrective actions.

Skills

Quality Assurance

GMP Regulations

Investigations

Documentation

Cross-functional Communication

Education

Bachelor’s degree in science/engineering

Job description

B. Braun Medical, Inc. in Irvine, CA is seeking a Quality Lead I to provide quality oversight for GMP manufacturing operations, ensuring timely QCRVs and IR handling, and coordinating cross‑functional activities to keep production ready.

The role requires strong knowledge of GMP, documentation practices, and quality systems, with the ability to train Quality Operations Associates and escalate issues to Quality Management. Regular on‑site attendance is required.