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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management systems, regulatory compliance, and process improvement within a plasma donor center environment. Proficient in root cause analysis, corrective actions, and training systems to ensure donor safety and product quality.
Highest-signal resume keywords
Quality Management System OversightRegulatory Compliance ExpertiseRoot Cause Analysis ProficiencyExperience in cGMP Regulated EnvironmentBachelor of Science Degree
About the role
Key responsibilities & impact- Evaluate processes, develop action plans, and coordinate strategic implementation of system processes and corrective actions at the plasma donor center
- Maintain oversight of the center’s quality management system and ensure continuous quality improvement
- Direct and monitor processes for compliance with state, federal, and company regulations
- Implement Standard Operating Procedures for quality control and regulatory compliance
- Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
- Supervise Quality Systems Associate personnel functions, including work assignment, hiring, development, training, discipline, termination, scheduling, and task follow-up
- Oversee internal and external audits, including preparation, execution, responses, corrective/preventive actions, and follow-up
- Assess and improve quality and training systems through trend recognition, failure investigation, and observations
- 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, and donor adverse event reports
- Ensure annual job and center training is completed and documented
- Perform employee training observations to verify staff competency
- Ensure supplies and materials meet quality requirements and are properly stored; initiate investigations or rejection when needed
- Determine donor suitability and manage donor deferrals and reinstatement approvals
- Prepare quality analysis reports and conduct research to resolve systemic compliance issues
- Ensure CLIA proficiency test surveys, complaint investigations, and training are documented
- Hold monthly Quality Meetings
- Lead projects and initiatives as requested
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Certified and proficient in quality and compliance
- Typically requires 2–5 years of related experience in a medical and/or cGMP regulated environment
- Experience with plasma or whole blood
- Ability to understand and assess FDA regulations
- Proficiency in root cause analysis and corrective/preventative actions
- High level of proficiency with computers
- Full command of mathematics
- Ability to travel when needed for meetings, events, and occasional support of other centers
- Ability to work with minimal supervision
- Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
Benefits
Comp & perks- Up to 20% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- PTO
- Paid holidays
- Tuition reimbursement
- Up to 5% 401(K) match
- Opportunities for professional growth and career progression
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 Control ProceduresTrend RecognitionProcess ImprovementData AnalysisMathematics ProficiencyQuality Analysis ReportingDonor Suitability AssessmentTraining System Development
Soft Skills
CollaborationLeadershipSupervisionCommunicationProblem-Solving
Tools & Technologies
Quality Management SoftwareAudit Management ToolsDocument Control SystemsTraining Management Systems
Certifications & Qualifications
Quality and Compliance Certification
Industry Keywords
Plasma DonationCGMP RegulationsFDA RegulationsBiohazard Waste ManagementCLIA Proficiency Testing