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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management systems, regulatory compliance, and training program oversight, ensuring donor safety and product quality through effective implementation of SOPs and corrective actions.
Highest-signal resume keywords
Quality Management SystemsRegulatory ComplianceStandard Operating Procedures (SOPs)Root-Cause AnalysisPersonnel 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 ControlCorrective/Preventive ActionsAuditsTraining SystemsCGMPCLIA Proficiency TestingDonor SuitabilityDeviations InvestigationCustomer Complaints ManagementBiohazard Waste Management
Soft Skills
CollaborationCommunicationLeadershipProblem-SolvingOrganizational Skills
Certifications & Qualifications
Bachelor of Science Degree
Industry Keywords
Blood-Borne Pathogen RequirementsQuality ImprovementTraining Records ManagementDonor SafetyProduct Quality
About the role
Key responsibilities & impact- Evaluate processes, develop action plans, and coordinate strategic implementation of quality system processes and corrective actions at the plasma donor center
- Maintain oversight of the center’s quality management system and drive continuous quality improvement
- Direct and monitor processes to ensure compliance with applicable regulations
- Implement SOPs for quality control and regulatory compliance
- Oversee the center training program, including training records, files, competency, and annual training completion
- Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
- Manage personnel functions for the Quality Associate
- Oversee internal and external audits, including preparation, execution, responses, corrective/preventive actions, and follow-up
- Assess trends, investigate procedure failures, and improve quality and training systems
- Document and investigate deviations and customer complaints; perform root-cause analysis
- Follow up on corrective/preventive actions, system implementations, and process improvement plans
- Oversee product and biohazard waste shipments, including regulatory compliance, labeling, documentation, and final shipment authorization
- Review unsuitable test results, unit lookback information, donor adverse event reports, and related documentation
- Ensure required job and center annual training is completed and documented
- Perform employee training observations to verify competency
- Ensure supplies and materials meet quality requirements and are stored appropriately; investigate and reject nonconforming supplies
- Determine donor suitability activities and manage donor deferrals and reinstatements
- Prepare quality analysis reports, research systemic compliance issues, and set goals
- Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented
- Hold monthly Quality Meetings to communicate status updates and manage action outcomes
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Ability to ensure compliance with applicable state, federal, and company-designated regulations
- Ability to implement Standard Operating Procedures (SOPs) for quality control and regulatory compliance
- Knowledge of quality management systems, training systems, audits, corrective/preventive actions, deviations, customer complaints, root-cause analysis, donor suitability, product quality, donor safety, CLIA proficiency testing, cGMP, and blood-borne pathogen requirements
- Ability to manage Quality Associate personnel functions, including hiring, development, training, scheduling, delegation, disciplinary actions, and termination