Quality Systems Associate

Grifols

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

Posted 10/12/2026full-timeMidwest City • Oklahoma • 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 analysis to ensure product quality and donor safety.

Highest-signal resume keywords

Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Documentation ReviewQuality ControlMathematics ProficiencySOP UnderstandingQuality Systems Knowledge

Soft Skills

Organizational SkillsAttention to DetailProblem-Solving SkillsIntegrityCommunication Skills

Tools & Technologies

Electronic Donor ChartTraining Records Management

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

FDA RegulationsQuality SpecificationsTraining ObservationsAdverse-Event ReportsPlasmapheresis Events

About the role

Key responsibilities & impact

Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
Complete weekly reviews of equipment QC and maintenance records
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
Perform documentation reviews 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 electronic donor chart 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 proper freezing, storage and handling
Create, maintain and audit training records and files
Perform employee training observations to verify competency before independent work
Conduct training for Center Notifications, Corporate Directives, SOP changes and initial SOP implementations
Review and approve deferred donor reinstatement activities when the Quality Systems Manager is absent
Assist with internal donor center audits when the Quality Systems Manager is absent
Review monthly trending reports
Review donor adverse-event reports and related documentation
Conduct training addressing donor center corrective and preventive measures
Communicate review issues to the CQM

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
Organizational skills and attention to detail
Ability to sit and review documentation for accuracy for 4 to 6 hours per day
Ability to stand for 2 to 4 hours per day
Ability to bend and twist the neck for 2 to 4 hours per day
Ability to make precise coordinated finger, hand and wrist movements
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 variable demands and changing conditions
Ability to relate sensitive information to diverse groups
Must be certified and maintain certification as a Donor Center Technician

Benefits

Comp & perks

Regular Full-Time employment
Personal protective equipment provided/required, including protective eyewear, garments, gloves and cold-gear