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Quality Systems Associate
GrifolsQuality Systems Associate managing quality assurance and training functions to ensure compliance with internal and external regulations. Working to support the quality standards in the healthcare sector at Grifols.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality control processes, regulatory compliance, and root-cause analysis, ensuring adherence to cGMP regulations and FDA standards. Proficient in documentation review and inspection of supplies to maintain product quality and donor safety.
Highest-signal resume keywords
Quality ControlRoot-Cause AnalysisCGMP Regulation ComplianceFDA Regulations UnderstandingDocumentation Review
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Mathematics KnowledgeDocumentation ReviewRoot-Cause AnalysisQuality ControlProduct Release Activities
Soft Skills
IntegrityCommitment to QualityFlexibility
Tools & Technologies
Computer Proficiency
Industry Keywords
CGMPFDA RegulationsSOPsPlasmapheresisDonor Safety
About the role
Key responsibilities & impact- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
- Inspects and releases incoming supplies.
- Investigates and reports supplies have not met quality specifications and requirements prior to use.
- Performs documentation review for unsuitable test results.
- Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
- Performs all product release activities.
- Reviews lookback information and documentation.
- Reviews waste shipment documentation.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
- Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
- Reviews donor deferral notifications from competitor centers.
- Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
Requirements
What you’ll need- High school diploma or GED
- Strong integrity and commitment to quality and compliance
- Good knowledge of mathematics
- Ability to understand FDA regulations
- Proficiency with computers
- Ability to work flexible scheduling to meet business needs
Benefits
Comp & perks- None specified 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score