Quality Systems Associate

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 quality control and maintenance records.
• Document, investigate, and conduct root‑cause analysis for deviations and customer complaints related to product quality or donor safety.
• Inspect and release incoming supplies, investigating and reporting supplies that do not meet quality specifications or requirements.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
• 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 for exceptions during the donation process.
• Review electronic donor chart exceptions impacting donor eligibility, safety, or product quality.
• Review donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage, and handling of product.
• Assist with center training programs to follow procedural requirements defined in the donor center SOP and training documents.
• Create, maintain, and audit training records and files to ensure compliance.
• Observe employee training to verify staff competency before they work independently.
• Conduct required training activities for Center 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 the completion of internal donor center audits.
• Perform review of monthly trending report.
• Perform review of donor adverse events reports and related documentation.
• Conduct training to address donor center corrective and preventative measures.

• Is certified and maintains certification as a Donor Center Technician.

• Developing command of interpersonal communication, organizational and problem‑solving skills.
• Ability to understand FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics.
• Legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Performs basic document review and employee observations.
• Communicates openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOPs and protocols.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
• Has a basic understanding of cGMP and quality systems.
• Is able to spend hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

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

Typically requires no previous related experience.

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold‑gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day.

The position does require bending and twisting of neck up from 2 to 4 hours per day.…