Quality Systems AssociateGrifols 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.
Summary: 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.
Primary Responsibilities: Completes weekly review of equipment QC and maintenance records.Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to product quality and/or donor safety.Inspects and releases incoming supplies, investigating and reporting supplies that have not met quality specifications and requirements prior to use.Performs documentation review for unsuitable test results.Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.Performs all product release activities.Reviews lookback information and documentation.Reviews waste shipment documentation.Reviews unexpected plasmapheresis events including electronic donor chart and related documentation.Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.Reviews donor deferral notifications from competitor centers.Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.Training Responsibilities: Assists the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.Creates, maintains, and audits training records and files to ensure compliance.Performs employee training observations to ensure staff competency prior to releasing employees to work independently.Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.When the Quality Systems Manager is absent, the Quality Systems Associate may be required to:Review and approve deferred donor reinstatement activities.Assist with completion of the internal donor center audit.Additional Responsibilities: Performs review of monthly trending report.Performs review of donor adverse events reports and the applicable related documentation.Conducts training to address donor center corrective and preventative measures.Education: High school diploma or GED.
Obtains 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 and potential exposure to infectious organisms.
Personal protective equipment is required.
Work mostly involves sitting for 4 to 6 hours per day and standing from 2 to 4 hours per day.
The position requires bending and twisting of neck, frequent hand movement, light lifting, and good hearing acuity.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. Learn more about Grifols here.
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