Quality Systems Specialist - Plasma Center

Grifols, S.A; Wichita (KS); On-site; USD 54,000 - 74,000; Full time

Job summary

Grifols, S.A. in Wichita, KS seeks a Quality Systems Associate to support QA and training functions ensuring compliance with cGMP and regulatory standards in a plasma center environment.

Under supervision of the Quality Systems Manager, you will review QC records, investigate deviations, release materials, and maintain training records while contributing to continuous improvement and patient safety.

Qualifications

• Understanding of FDA regulations and cGMP requirements.
• Strong interpersonal communication and teamwork abilities.
• Analytical mindset with attention to detail and problem-solving skills.
• Excellent organizational skills and documentation discipline.
• Computer literacy and ability to manage electronic records.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Investigates deviations and donor safety-related quality issues.
• Inspects and releases incoming supplies; reports nonconformances.
• Performs documentation review for test results and releases.
• Ensures adherence to cGMP, SOPs and regulatory requirements.
• Assists manager with center training programs and records.
• Performs monthly review of donor center training and audits.
• Reviews donor adverse events reports and related documentation.
• Provides training on corrective and preventive actions.

Skills

FDA regulations

Interpersonal communication

Problem solving

Organizational skills

Proficiency with computers

Education

High school diploma or GED

Job description

Grifols, S.A. in Wichita, KS seeks a Quality Systems Associate to support QA and training functions ensuring compliance with cGMP and regulatory standards in a plasma center environment.

Under supervision of the Quality Systems Manager, you will review QC records, investigate deviations, release materials, and maintain training records while contributing to continuous improvement and patient safety.