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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 continuous quality improvement within a plasma donor center environment. Proficient in root cause analysis, corrective actions, and training program oversight to ensure donor safety and product quality.
Highest-signal resume keywords
Quality Management SystemsRegulatory ComplianceRoot Cause AnalysisCGMP ExperienceTraining Program Oversight
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Root Cause AnalysisCorrective ActionsQuality ControlRegulatory ComplianceData AnalysisMathematics SkillsSOP ImplementationQuality Analysis ReportingDonor Suitability AssessmentAudit Preparation
Soft Skills
CollaborationIndependent WorkProblem SolvingConsensus BuildingCommunication
Tools & Technologies
Quality Management SoftwareTraining Management SystemsData Analysis ToolsDocument Management Systems
Certifications & Qualifications
Bachelor of Science Degree
Industry Keywords
Plasma DonationCGMP RegulationsFDA RegulationsBiological FluidsInfectious OrganismsQuality ImprovementTraining ComplianceInternal AuditsExternal AuditsBiohazard Waste Management
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
- Ensure compliance with applicable state, federal, and company regulations
- Implement SOPs for quality control and regulatory compliance
- Oversee the center training program, audit training records, and maintain training files
- Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
- Direct and manage Quality Systems Associate personnel functions, including work assignment, hiring, development, training, discipline, termination, scheduling, and follow-up
- Oversee internal and external audits, including preparation, execution, responses, corrective/preventive actions, and follow-up
- Assess trends, investigate procedural failures, and improve quality and training systems
- Document deviations and customer complaints and perform root-cause analysis
- Investigate trends and 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 annual job and center training is completed and documented
- Observe employee training to verify competency before independent work
- Verify 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 and research systemic compliance issues
- Ensure CLIA proficiency-test surveys, complaint investigations, and training are documented
- Hold monthly Quality Meetings to communicate updates and manage action outcomes
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Equivalency may include directly related experience or a combination of directly related education and experience and/or competencies in place of stated requirements
- Typically requires 2 years of related experience in a medical and/or cGMP regulated environment
- Experience with plasma or whole blood preferred
- Ability to understand and assess FDA regulations
- Proficiency in root cause analysis and corrective/preventative actions
- High level of proficiency with computers
- Strong mathematics skills
- Ability to travel when needed for meetings, events, and occasional support of other centers
- Ability to work independently with minimal supervision
- Ability to work with diverse groups to obtain consensus
- Ability to apply abstract principles to solve complex conceptual issues
- Ability to work in office and/or laboratory/manufacturing environments with exposure to biological fluids, infectious organisms, chemicals, machinery, noise, and extreme cold
- Ability to use required personal protective equipment
- Ability to frequently sit for 6–8 hours per day and perform repetitive hand movements
- Ability to lift and carry up to 35 lbs
- Ability to frequently drive to site locations and travel occasionally within the United States
Benefits
Comp & perks- Medical insurance
- Paid time off (PTO)
- Up to 5% 401(k) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like company culture