Quality Systems Associate: Training & Compliance

Grifols; Alexandria (LA); On-site; USD 55,000 - 75,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to support the Quality Systems Manager in ensuring compliance with internal and external regulations and protocols. The role involves quality assurance, training, and product release activities within a plasma center environment.

The candidate will assist with SOP adherence, documentation review, and deviation investigations to maintain high standards of donor safety and product quality.

Qualifications

• High school diploma or GED; state licensures or certifications if applicable.
• Typically requires no previous related experience.
• Developing command of FDA regulations and quality systems is expected.
• Ability to review documents and train staff in procedures.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and analyzes deviations and customer complaints related to quality and donor safety.
• Inspects and releases incoming supplies and reports quality issues before use.
• Performs documentation review for unsuitable test results.
• Assists Quality Systems Manager to ensure cGMP compliance and SOP adherence.
• Performs product release activities and reviews related documentation.
• Reviews lookback information, waste shipment documentation, and donor events.

Skills

Quality Assurance

cGMP

Documentation

Training

Regulatory awareness

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate to support the Quality Systems Manager in ensuring compliance with internal and external regulations and protocols. The role involves quality assurance, training, and product release activities within a plasma center environment.

The candidate will assist with SOP adherence, documentation review, and deviation investigations to maintain high standards of donor safety and product quality.