Quality Systems Associate

Grifols

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

Posted 9/17/2026full-timeFayetteville • North Carolina • 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 to ensure product quality and donor safety.

Highest-signal resume keywords

Quality AssuranceCGMP ComplianceRoot-Cause AnalysisTraining and DevelopmentDocumentation Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlMathematics ProficiencySOP UnderstandingDocumentation ReviewProduct Release Activities

Soft Skills

Interpersonal CommunicationOrganizational SkillsProblem-Solving SkillsIntegrityCommitment to Quality

Tools & Technologies

Computer Proficiency

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

FDA RegulationsCGMPQuality SystemsTraining RecordsDonor Safety

About the role

Key responsibilities & impact

Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
Review equipment QC 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 and investigate nonconforming supplies before use
Review documentation for unsuitable test results
Ensure compliance with cGMP regulations, SOPs, and regulatory requirements
Perform product release activities
Review lookback information and documentation
Review waste shipment documentation
Review unexpected plasmapheresis events and electronic donor chart exceptions
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
Conduct required 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 and donor adverse-event reports
Conduct training addressing donor center corrective and preventive measures
Maintain certification as a Donor Center Technician

Requirements

What you’ll need

High school diploma or GED
Obtains state licensures or certifications if applicable
Typically requires no previous related experience
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
Ability to sit and review documentation for 4 to 6 hours per day
Ability to stand for 2 to 4 hours per day
Ability to lift 15 lbs., with a maximum lift of 50 lbs.
Hearing acuity essential
Correctable near and far vision requirements
Ability to communicate and understand spoken information
Ability to work independently with little guidance
Ability to perform a wide range of tasks under changing conditions

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