Quality Associate II (Pharmaceutical)

TL;DR

Quality Associate II (Pharmaceutical): Supporting raw material quality control through sampling and testing in a cGMP environment with an accent on laboratory documentation and instrument calibration. Focus on ensuring data integrity, conducting process verifications, and maintaining audit readiness for quality release.

Location: Fully onsite in Irvine, California, United States

Compensation: $28.41 - $30.81 per hour

Company

B. Braun Medical Inc. is a global leader in infusion therapy and pain management, developing and manufacturing innovative medical products for the healthcare industry.

What you will do

• Perform sampling of incoming raw materials and conduct routine physical and identification testing.
• Manage the Raw Material retain program and perform daily instrument calibration and maintenance.
• Monitor manufacturing process verifications to ensure strict compliance with operating procedures and specifications.
• Provide quality oversight by reviewing reports, metadata, and records to support product distribution.
• Ensure adherence to regulatory requirements outlined by FDA, ICH, and the internal Quality System.
• Review all laboratory documentation to ensure data integrity meets industry standards.

Requirements

• High school diploma/G.E.D or equivalent (Associate's or technical degree preferred).
• 1-2 years of related experience.
• Regular and predictable on-site attendance in Irvine, CA.

Culture & Benefits

• Comprehensive healthcare benefits package.
• 401(k) retirement plan.
• Tuition reimbursement programs.
• Collaborative environment based on the "Sharing Expertise" philosophy for continuous improvement.