Quality Systems Associate

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 QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints, specifically in how they relate to product quality and/or donor safety.
• Inspect and release incoming supplies. Investigate and report supplies that have not met quality specifications and requirements prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure that 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 pertaining to exceptions occurring during the donation process.
• 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 the 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 prior to releasing employees to work independently.
• 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 report.
• Perform review of donor adverse events reports and the applicable 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. Obtains 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. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers,…