Quality Systems Associate

Grifols

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

Posted 11/6/2026full-timeBoise • Idaho • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates proficiency in quality assurance processes, including compliance with cGMP regulations and SOPs, while effectively communicating and training staff on quality standards and procedures. 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 CertificationInterpersonal Communication

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality ControlDocumentation ReviewRoot-Cause AnalysisMathematics ProficiencySOP UnderstandingFDA Regulations KnowledgeTraining Record MaintenanceProduct Release ActivitiesData AnalysisQuality Systems Knowledge

Soft Skills

Organizational SkillsAttention to DetailProblem-Solving SkillsCommunication SkillsIndependence

Tools & Technologies

Electronic Donor Chart SystemsQuality Management SystemsTraining Management Software

Certifications & Qualifications

Donor Center Technician Certification

Industry Keywords

CGMPSOPsRegulatory ComplianceDonor SafetyQuality Assurance

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
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
Communicate issues identified during reviews to the CQM

Requirements

What you’ll need

High school diploma or GED
Typically requires no previous related experience
Must 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
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
Certified and maintains certification as a Donor Center Technician
Ability to perform required physical duties, including sitting, standing, bending, twisting, precise hand movements, squatting/crouching occasionally, and lifting up to 50 lbs.
Hearing acuity essential; color perception/discrimination and correctable near and far vision requirements
Ability to communicate information clearly 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

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