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 root-cause analysis and maintaining accurate documentation while ensuring donor safety and product quality.

Highest-signal resume keywords

CGMP ComplianceQuality AssuranceRoot-Cause AnalysisDonor Center Technician CertificationInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsDocumentation ReviewMathematics ProficiencySOP UnderstandingBiological Fluids Handling

Soft Skills

Organizational SkillsProblem-Solving SkillsAttention to DetailEffective CommunicationIndependence

Tools & Technologies

Computer Proficiency

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

FDA RegulationsQuality ComplianceTraining RecordsPlasma ProcessingAdverse Event Reporting

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 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 electronic donor chart exceptions
Review donor deferral notifications from competitor centers
Review plasma processing documentation for freezing, storage and handling
Create, maintain and audit training records and files
Perform employee training observations to confirm 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 and donor adverse event reports
Conduct training addressing donor center corrective and preventative measures
Communicate issues identified during reviews to the CQM

Requirements

What you’ll need

High school diploma or GED
Typically requires no previous related experience
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
Ability to spend hours sitting and reviewing documentation for accuracy
Good organizational skills and attention to detail
Must be certified and maintain certification as a Donor Center Technician
Ability to work with biological fluids and potentially infectious organisms
Ability to lift up to 50 lbs. and perform required bending, twisting, standing and sitting
Hearing acuity essential; correctable near and far vision and color perception/discrimination
Ability to communicate information effectively and listen to 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

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