Quality Systems Associate

3 days ago Be among the first 25 applicants. Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events, including electronic donor chart and related documentation.
• Review electronic donor chart exceptions impacting donor eligibility, safety and/or product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage and handling of product.
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competency.
• Conduct required training activities for center notifications, corporate directives, SOP changes and initial SOP implementations.
• Review and approve deferred donor reinstatement activities.
• Assist with completion of the internal donor center audit.
• Perform review of monthly trending reports.
• Perform review of donor adverse events reports and related documentation.
• Conduct training to address donor center corrective and preventive measures.

• Maintain certification as a Donor Center Technician.

• High school diploma or GED; obtain state licensure or certifications if applicable.
• Typically requires no previous related experience.
• Developing command of interpersonal communication, organizational and problem‑solving skills.
• Ability to understand FDA regulations, SOPs and protocols.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics and legible handwriting.
• Proficiency with computers and ability to work flexible scheduling to meet business needs.
• Performs basic document review and employee observations.
• Demonstrates good organizational skills and attention to detail; ability to spend hours reviewing documentation for accuracy.
• Basic understanding of cGMP and quality systems.

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms, electrical office and laboratory equipment, and extreme cold below 32°F while performing reviews in plasma freezers. Requires sitting 4‑6 hours per day and standing 2‑4 hours per day; bending, twisting, and frequent hand movements are required. Light lifting of up to 15 lbs, with a maximum lift of 50 lbs.

Requires hearing acuity, color perception/discrimination, and near vision of 20/30 and far vision of 20/100 in the other eye. Ability to communicate information and ideas clearly and to listen to and understand information presented through spoken words and sentences. Performs a wide range of tasks as dictated by variable demands and changing conditions.

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,…