Quality Systems Associate

Grifols

. Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager .

Posted 11/2/2026full-timeFt Myers • Florida • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates proficiency in quality assurance processes, compliance with cGMP regulations, and effective training methodologies. Capable of conducting root-cause analysis and maintaining accurate documentation while ensuring donor safety and product quality.

Highest-signal resume keywords

CGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationQuality AssuranceInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlDocumentation ReviewMathematics ProficiencySOP UnderstandingBiological Fluids HandlingLaboratory Equipment OperationPlasma Freezer OperationTraining Record MaintenanceData AnalysisAttention to Detail

Soft Skills

Organizational SkillsProblem-Solving SkillsIntegrityCommunication SkillsAbility to Work Independently

Tools & Technologies

Quality SystemsTraining SoftwareDocumentation Management Systems

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

FDA RegulationsSOPsQuality AssuranceDonor SafetyPlasmapheresisCompliance Standards

About the role

Key responsibilities & impact

Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
Review equipment quality-control and maintenance records weekly
Document, investigate and perform root-cause analysis for deviations and customer complaints related to product quality or donor safety
Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications
Review documentation for unsuitable test results
Ensure 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 and related donor-chart documentation
Review donor-chart exceptions affecting donor eligibility, donor safety or product quality
Review donor deferral notifications from competitor centers
Review plasma processing documentation for proper freezing, storage and handling
Create, maintain and audit training records and files
Perform employee training observations to verify staff competency
Conduct training 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 internal donor center audits
Review monthly trending reports
Review donor adverse-event reports and related documentation
Conduct training addressing donor-center corrective and preventive measures

Requirements

What you’ll need

High school diploma or GED
Typically requires no previous related experience
Must obtain state licensures or certifications if applicable
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
Ability to understand and follow SOPs and protocols
Basic understanding of cGMP and quality systems
Good organizational skills and attention to detail
Ability to spend hours sitting and reviewing documentation for accuracy
Must be certified and maintain certification as a Donor Center Technician
Ability to work with biological fluids, laboratory equipment, plasma freezers and required PPE
Ability to lift up to 50 pounds
Hearing acuity essential; correctable near and far vision requirements specified
Ability to communicate information and understand spoken information
Ability to work independently with little guidance
Ability to perform a wide range of tasks under variable demands and changing conditions
Ability to relate sensitive information to diverse groups

Benefits

Comp & perks

Equal employment opportunities and consideration consistent with applicable laws
Personal protective equipment provided/required, including protective eyewear, garments, gloves and cold-gear