Quality Systems Associate

Grifols, S.A; Brookings (SD); On-site; USD 35,000 - 45,000; Full time

Job summary

Grifols, S.A in Brookings, SD is seeking a Quality Systems Associate to perform quality assurance and training functions ensuring compliance with internal and external regulations. This is an entry-level role that entails documenting and investigating product quality deviations, inspecting incoming supplies, and supporting training programs.

Applicants should possess a high school diploma or GED with no previous experience required. Strong communication and organizational skills are essential. Opportunity for certification as a Donor Center Technician is also provided.

Qualifications

• Strong interpersonal communication, organizational, and problem-solving skills.
• Understanding of FDA regulations, cGMP, and quality systems.
• Integrity and commitment to quality and compliance.

Responsibilities

• Perform quality assurance and training functions to ensure compliance.
• Document, investigate, and perform root-cause analysis for deviations.
• Inspect and release incoming supplies, reporting any non-conformances.
• Assist in ensuring cGMP regulations and SOPs are followed.

Skills

Interpersonal communication

Organizational skills

Problem-solving skills

Understanding of FDA regulations

Basic mathematics

Computer proficiency

Attention to detail

Education

High school diploma or GED

Job description

Would you like to join an international team working to improve the future of healthcare? Our global healthcare company, founded in 1909, is a leader in plasma‑derived medicines and transfusion medicine, developing, producing and marketing innovative medicines, solutions and services in over 110 countries.

Quality Systems Associate

Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.

Summary

• Review equipment QC and maintenance records on a weekly basis.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and donor safety.
• Inspect and release incoming supplies, reporting any non‑conformances.
• Review documentation for unsuitable test results.
• Assist in ensuring cGMP regulations, SOPs, and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information, waste shipment documentation, and unexpected plasmapheresis events, including donor chart exceptions and donor deferral notifications.
• Review plasma processing documentation to confirm proper freezing, storage, and handling of product.
• Support center training programs: create, maintain, and audit training records; observe employee training; conduct training activities for notifications, corporate directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with internal donor center audits.

Additional Responsibilities

Maintain certification as a Donor Center Technician.

Knowledge, Skills, and Abilities

• Strong interpersonal communication, organizational, and problem‑solving skills.
• Understanding of FDA regulations, cGMP, and quality systems.
• Integrity and commitment to quality and compliance.
• Basic mathematics, legible handwriting, and computer proficiency.
• Flexibility to work varied schedules to meet business needs.
• Ability to perform detailed document reviews and employee observations.
• Good organizational skills and attention to detail.
• Capacity for prolonged sitting and document review.

Education

High school diploma or GED. Obtain state licensures or certifications if applicable.

Experience

Typically requires no previous related experience.

Occupational Demands

Work is performed in a plasma center with exposure to biological fluids, electrical equipment, and extreme cold. Personal protective equipment (PPE) is required. The role involves sitting for 4–6 hours per day, standing 2–4 hours per day, bending, twisting, frequent hand and foot movements, and lifting 15–50 lbs as needed. Vision and hearing acuity are essential.

EEO Statement

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, or disability. Qualified applicants will be considered in accordance with applicable laws.

Location

NORTH AMERICA : USA : SD-Brookings:BTBRK - Brookings SD-22nd Ave S-BPC