Quality Systems Associate

About the role

Join an international team dedicated to improving healthcare. Grifols is a global leader in plasma-derived medicines and transfusion medicine, operating in over 110 countries.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in relation to product quality and donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies that do not meet quality specifications and requirements before use.
• Performs documentation review for unsuitable test results.
• Affixes to the Quality Systems Manager to ensure compliance with internal and external regulations and protocols.
• 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 pertaining to exceptions occurring during the donation process.
• 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.
• Affixes to 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.
• On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
• Reviews and approves of deferred donor reinstatement activities.
• Assists with completion of the internal donor center audit.
• 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.

Qualifications

• Is certified and maintains certification as a Donor Center Technician.
• Develops command of interpersonal communication, organizational, and problem-solving skills.
• Understands 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 SOP’s 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.

Education

• High school diploma or GED.
• Obtains state licensures or certifications if applicable.

Experience

• Typically requires no previous related experience.