Quality Systems Associate

Grifols

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

Posted 10/6/2026full-timeFort Worth • Texas • 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 thorough documentation reviews and root-cause analyses to ensure product quality and donor safety.

Highest-signal resume keywords

Quality AssuranceCGMP ComplianceFDA Regulations UnderstandingDonor Center Technician CertificationRoot-Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Document ReviewRoot-Cause AnalysisQuality ControlMathematics ProficiencySOP Understanding

Soft Skills

Interpersonal CommunicationOrganizational SkillsProblem-Solving SkillsIntegrityCommitment to Quality

Tools & Technologies

Quality SystemsTraining Records Management

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

CGMPFDA RegulationsQuality AssuranceDonor SafetySOPs

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 documentation
Review electronic donor chart exceptions affecting donor eligibility, donor safety, or product quality
Review donor deferral notifications from competitor centers
Review plasma processing documentation for freezing, storage, and handling
Create, maintain, and audit training records and files
Observe employee training to verify competency before independent work
Conduct training for center notifications, corporate directives, SOP changes, and initial SOP implementations
Review monthly trending reports and donor adverse-event reports
Conduct training addressing donor-center corrective and preventive measures
When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with internal donor-center audits

Requirements

What you’ll need

High school diploma or GED
Must obtain applicable state licensures or certifications, if applicable
Donor Center Technician certification must be maintained
Typically requires no previous related experience
Understanding of FDA regulations
Basic understanding of cGMP and quality systems
Ability to understand and follow SOPs and protocols
Proficiency with computers
Good knowledge of mathematics
Developing interpersonal communication, organizational, and problem-solving skills
Strong integrity and commitment to quality and compliance
Ability to work flexible schedules to meet business needs
Ability to perform document review and employee observations
Ability to sit and review documentation for 4–6 hours per day and stand for 2–4 hours per day
Ability to perform required physical movements and lift 15 pounds, with a maximum lift of 50 pounds
Hearing acuity and correctable near and far vision requirements
Ability to communicate and understand spoken information
Ability to work independently with little guidance
Ability to perform varied tasks under changing conditions
Ability to relate sensitive information to diverse groups

Benefits

Comp & perks

Regular full-time employment
Personal protective equipment provided/required, including protective eyewear, garments, gloves, and cold-gear
Equal employment opportunity protections