Quality Assurance Specialist — GMP & Compliance

Linde Gas & Equipment; Los Angeles (CA); On-site; USD 63,000 - 93,000; Full time

Job summary

Linde Gas & Equipment in Los Angeles, CA seeks a Quality Assurance Specialist for 1st Shift to ensure Batch Production Records compliance and drive corrective actions. You will review manufacturing steps and coordinate investigations.

The role emphasizes FDA regulations for medical products, quality investigations, GMP training, and supporting continuous quality improvements and product disposition decisions.

Qualifications

• Bachelor’s or Associate’s degree in science, engineering, or a related technical field.
• Knowledge of FDA regulations for medical products (21 CFR parts 210 and 211).
• Experience with ISO 9001/13485 is advantageous.
• Strong communication and organizational skills.
• Experience in quality assurance for medical products preferred.

Responsibilities

• Review steps to ensure manufacturing processes comply with Batch Production Records.
• Report in-process errors and ensure corrective actions are completed.
• Coordinate quality investigations and implement CAPA actions.
• Support product quality complaint investigations and adverse event data processing.
• Conduct quality reviews of preventive maintenance and support quality improvements.
• Provide training on GMP and quality principles across departments.
• Assist tracking deviations and complaints to support quality monitoring.
• Ensure product disposition approvals including release, distribution or rejection.

Skills

Quality assurance

Regulatory knowledge

Communication skills

Organizational agility

Microsoft Office

Lotus Notes

HTML basics

JavaScript basics

Education

Bachelor’s or Associate’s degree in Science, Engineering, or related technical field

Tools

Microsoft Office

Lotus Notes

HTML

JavaScript

Job description

Linde Gas & Equipment in Los Angeles, CA seeks a Quality Assurance Specialist for 1st Shift to ensure Batch Production Records compliance and drive corrective actions. You will review manufacturing steps and coordinate investigations.

The role emphasizes FDA regulations for medical products, quality investigations, GMP training, and supporting continuous quality improvements and product disposition decisions.