Quality Systems Associate

Grifols

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

Posted 10/26/2026full-timeEverett • Washington • United StatesJuniorMid-Level💰 $24 - $33 per hourWebsite

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 ComplianceRoot-Cause AnalysisDonor Center Technician CertificationDocumentation Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlRoot-Cause AnalysisDocumentation ReviewMathematics KnowledgeCGMP UnderstandingSOP ComplianceProduct Release ActivitiesTraining Record MaintenanceBiological Fluid HandlingEquipment Inspection

Soft Skills

Organizational SkillsProblem-Solving SkillsAttention to Detail

Tools & Technologies

Laboratory EquipmentPersonal Protective Equipment

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

FDA RegulationsQuality SystemsAdverse Event ReportingPlasmapheresis EventsTraining Observations

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 specifications
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 freezing, storage, and handling
Create, maintain, and audit training records and files
Conduct employee training observations and required training activities
Review monthly trending reports and donor adverse-event reports
Conduct training addressing corrective and preventive measures
Occasionally review and approve deferred donor reinstatement activities and assist with internal donor-center audits when the Quality Systems Manager is absent
Communicate issues noted during reviews to the CQM

Requirements

What you’ll need

High school diploma or GED
Typically no previous related experience required
Donor Center Technician certification must be maintained
Obtain state licensures or certifications if applicable
Ability to understand FDA regulations
Knowledge of mathematics
Computer proficiency
Ability to work flexible schedules to meet business needs
Ability to understand and follow SOPs and protocols
Basic understanding of cGMP and quality systems
Strong organizational, problem-solving, and attention-to-detail skills
Ability to review documentation for accuracy and perform employee observations
Ability to sit and review documentation for 4–6 hours per day and stand 2–4 hours per day
Ability to lift 15 lbs., with a maximum lift of 50 lbs.
Hearing acuity and correctable near/far vision requirements
Ability to work with biological fluids, infectious organisms, electrical/laboratory equipment, and extreme cold below 32°F
Ability to use required personal protective equipment

Benefits

Comp & perks

Up to 5% company bonus pool
Medical insurance
Dental insurance
Vision insurance
Life insurance
PTO
Paid holidays
Up to 5% 401(k) match
Tuition reimbursement
Professional growth and career progression opportunities
Personal protective equipment provided/required