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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality assurance and regulatory compliance, with a strong focus on process improvement, training, and personnel management. Proficient in conducting audits, root-cause analysis, and ensuring adherence to quality standards and SOPs.
Highest-signal resume keywords
Quality AssuranceRegulatory ComplianceRoot-Cause AnalysisCertified Quality AuditorPersonnel Management
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 ControlProcess ImprovementTrend AnalysisDocument ReviewEquipment CalibrationSOP VerificationCGMP TrainingQuality Analysis ReportingAudit ManagementFailure Investigation
Soft Skills
CollaborationDecision-MakingCommunicationCustomer SatisfactionTeam Development
Certifications & Qualifications
Bachelor of Science DegreeCertified Quality AuditorDesignated Trainer Certification
Industry Keywords
Quality StandardsDonor SafetyBiohazard Waste ManagementCLIA Proficiency SurveysSOPsQuality SystemsDonor SuitabilityCorrective ActionsInternal AuditsExternal Audits
About the role
Key responsibilities & impact- Ensure center compliance with quality standards, regulations, SOPs, and company requirements
- Collaborate with Center Managers on product quality, donor suitability, and donor safety
- Direct and monitor quality-control and regulatory-compliance processes
- Interpret and implement processes, regulations, and SOPs; make independent decisions and modifications
- Oversee internal and external audits, documentation, responses, and corrective/preventive actions
- Assess and improve quality systems through trend recognition, failure investigation, employee observation, and document review
- Manage Quality Associate personnel functions, including work assignment, hiring, development, training, discipline, and termination
- Oversee product and biohazard waste shipments, including labeling, documentation, and final authorization
- Review unsuitable test results and associated dispositions
- Investigate deviations and customer complaints and perform root-cause analysis
- Track and trend quality incidents; report critical incidents and problematic trends to the Center Manager
- Report compliance status to relevant parties
- Ensure donor-file accuracy
- Direct equipment maintenance, calibration, and procedure documentation
- Ensure CLIA proficiency surveys, complaint investigations, and training are documented
- Monitor training documentation and completion of job and cGMP training
- Ensure QC checks for test reagents are performed and within acceptable ranges
- Verify SOPs and forms are current in the Donor Center manual
- Partner with the Center Manager on donor suitability and donor deferrals
- Prepare quality-analysis reports and research systemic compliance issues
- Build rapport with donors to support customer satisfaction and long-term donation
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Certified and proficient in quality and compliance
- Works toward certification from American Society for Quality to be a Certified Quality Auditor
- Certification as a Designated Trainer for quality area is required