Quality Assurance Systems Specialist

Grifols; Town of Texas (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to ensure compliance with cGMP and SOPs, performing QA and training under the Quality Systems Manager. The role involves reviewing equipment QC, deviations, and donor-related documentation to maintain product safety and quality.

Responsibilities include product release activities, supplier inspections, and ensuring regulatory alignment within a plasma center setting. Strong attention to detail and regulatory understanding are essential.

Qualifications

• Quality assurance and training to ensure compliance with cGMP and SOPs.
• Investigates deviations and donor safety-related issues affecting product quality.
• Reviews documentation, including donor charts and regulatory records.
• Maintains training records and conducts employee training observations.

Responsibilities

• Weekly review of equipment QC and maintenance records.
• Investigate deviations and customer complaints related to quality.
• Inspect incoming supplies and report non-conforming items.
• Perform product release activities and review related documentation.
• Assist QA Manager to ensure compliance with SOPs and regulatory requirements.
• Review donor center events, adverse events, and corrective actions.

Skills

Quality Assurance

Root-Cause Analysis

Documentation Review

Training

cGMP Compliance

Regulatory Knowledge

Donor Center Experience

Education

High school diploma or GED

Job description

Grifols is seeking a Quality Systems Associate to ensure compliance with cGMP and SOPs, performing QA and training under the Quality Systems Manager. The role involves reviewing equipment QC, deviations, and donor-related documentation to maintain product safety and quality.

Responsibilities include product release activities, supplier inspections, and ensuring regulatory alignment within a plasma center setting. Strong attention to detail and regulatory understanding are essential.