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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.
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
ATS Keywords
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Hard Skills & Tools
Mathematics KnowledgeDocumentation ReviewRoot-Cause AnalysisQuality ControlProduct Release Activities
Soft Skills
IntegrityCommitment to QualityFlexibility