Quality Assurance & Training Specialist - Donor Center

Grifols; Brookings (SD); On-site; USD 35,000 - 52,000; Full time

Job summary

Grifols seeks a Quality Systems Associate to support quality assurance and training activities in a plasma center environment. You will ensure compliance with internal procedures, perform product release tasks, and assist the Quality Systems Manager with training and documentation duties.

The role emphasizes adherence to FDA regulations, cGMP, and SOPs, with duties ranging from reviewing equipment records to handling deviations and audits.

Qualifications

• High school diploma or GED; state licensures or certifications if applicable.
• Typically requires no previous related experience.
• Knowledge of FDA regulations and cGMP preferred.
• Flexibility in scheduling to meet business needs.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints related to quality and donor safety.
• Inspects and releases incoming supplies; investigates and reports supplies not meeting quality specs.
• Performs documentation review for unsuitable test results.
• Supports Center training programs and SOP changes.
• Performs product release activities under supervision.
• Reviews donor and processing documentation to ensure proper handling of product.
• Reviews adverse events and corrective/preventive actions.

Skills

Interpersonal communication

Organizational skills

Problem solving

Computer proficiency

Attention to detail

Education

High school diploma or GED

Job description

Grifols seeks a Quality Systems Associate to support quality assurance and training activities in a plasma center environment. You will ensure compliance with internal procedures, perform product release tasks, and assist the Quality Systems Manager with training and documentation duties.

The role emphasizes adherence to FDA regulations, cGMP, and SOPs, with duties ranging from reviewing equipment records to handling deviations and audits.