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Core Competencies
Role fitCore 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 accurate documentation to ensure product quality and donor safety.
Highest-signal resume keywords
Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationFDA Regulations Understanding
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality SystemsDocumentation ReviewTraining Record MaintenanceDeviation InvestigationProduct Release Activities
Soft Skills
Attention to DetailFlexible SchedulingCommunication Skills
Tools & Technologies
Laboratory EquipmentComputer Proficiency
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
CGMPSOPsRegulatory RequirementsBiological FluidsAdverse-Event Reporting
About the role
Key responsibilities & impact- Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
- Review equipment QC 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 all product release activities
- Review lookback information, waste shipment documentation, donor charts, donor eligibility/safety exceptions, competitor-center deferral notifications, and plasma processing documentation
- Create, maintain, and audit training records and files
- Perform employee training observations and conduct required training activities
- Review monthly trending reports and donor adverse-event reports
- Conduct training addressing donor-center corrective and preventive measures
- When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with internal donor-center audits
Requirements
What you’ll need- High school diploma or GED
- Obtains state licensures or certifications if applicable
- Ability to understand FDA regulations
- 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
- Donor Center Technician certification must be maintained
- Exposure to biological fluids, infectious organisms, electrical office and laboratory equipment, and extreme cold while reviewing plasma freezers
- Ability to lift 15 lbs routinely, with a maximum lift of 50 lbs
- Hearing acuity and correctable near/far vision requirements
- Typically requires no previous related experience