Grifols

Quality Systems Associate

Grifols
Posted 10/21/2026full-timeInkster • Michigan • United StatesJuniorMid-LevelWebsite
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Core Competencies

Role fit
Core Competencies

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

Demonstrates proficiency in quality assurance processes, compliance with cGMP regulations, and effective training methodologies. Capable of conducting root-cause analysis and maintaining meticulous documentation to ensure product quality and donor safety.

Highest-signal resume keywords
Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationTraining and Development

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 proper freezing, storage, and handling
  • Create, maintain, and audit training records and files
  • Perform employee training observations to verify 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 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
  • Must maintain certification as a Donor Center Technician
  • Developing 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
  • Attention to detail and organizational skills
  • Ability to work in a plasma center with exposure to biological fluids, infectious organisms, electrical equipment, and temperatures below 32°F
  • Ability to perform required physical demands, including sitting 4–6 hours per day, standing 2–4 hours per day, bending/twisting, frequent hand and foot movements, and lifting 15 lbs. (maximum 50 lbs.)
  • Hearing acuity and correctable near/far vision requirements
  • Ability to communicate, listen, work independently, and 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

ATS Keywords

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Applicant Tracking System Keywords

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

Hard Skills
Quality ControlDocumentation ReviewMathematics ProficiencySOP UnderstandingQuality Systems Knowledge
Soft Skills
Interpersonal CommunicationOrganizational SkillsProblem-Solving SkillsAttention to Detail
Tools & Technologies
Computer Proficiency
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
FDA RegulationsBiological FluidsInfectious OrganismsPlasma Center OperationsQuality Assurance Standards