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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 continuous quality improvement within a plasma donor center environment. Proficient in root cause analysis, corrective actions, and maintaining 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 drive continuous quality improvement
- Direct and monitor processes to ensure compliance with state, federal, and company regulations
- Implement SOPs for quality control and regulatory compliance
- Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
- Manage personnel functions for the Quality Systems Associate, including work assignment, hiring, development, training, discipline, termination, records, 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 investigations, and observations
- Document and investigate deviations and customer complaints and perform root-cause analysis
- Track corrective and preventive actions, system implementations, and process improvement plans for effectiveness
- 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
- Ensure supplies meet quality requirements and are properly stored; investigate or reject non-compliant supplies
- Determine donor suitability, manage donor deferrals, and review/approve deferred donor reinstatements
- 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 and manage action outcomes
- 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 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/preventive actions
- High level of computer proficiency
- Strong mathematics proficiency
- Ability to travel when needed for meetings, events, and occasional support of other centers
- Ability to work with minimal supervision
- Ability to work in office and/or laboratory/manufacturing environments with exposure to biological fluids, chemicals, machinery, noise, and cold temperatures
- Ability to use required personal protective equipment
- Ability to frequently sit for 6–8 hours per day
- Ability to lift and carry up to 35 pounds
- Ability to frequently drive to site locations with occasional travel within the United States
Benefits
Comp & perks- Full healthcare benefits
- Medical, dental, and vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(k) match
- Tuition reimbursement
- Academy courses that may count for college credit
- Professional growth and career progression opportunities
- Relocation assistance of up to $20K
- Eligibility to participate in up to 20% of the company bonus pool
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 Control ImplementationCorrective/Preventive ActionsTrend RecognitionFailure InvestigationsData AnalysisMathematics ProficiencySOP DevelopmentAudit Preparation and ExecutionDocumentation and InvestigationDonor Suitability Assessment
Soft Skills
CollaborationLeadershipTraining and DevelopmentProblem-SolvingCommunication
Tools & Technologies
Quality Analysis ReportsPersonal Protective EquipmentLaboratory EquipmentComputer Proficiency
Certifications & Qualifications
Quality and Compliance Certification
Industry Keywords
Plasma DonationFDA RegulationsCGMPBiological FluidsMedical EnvironmentInternal and External AuditsDonor Adverse Event ReportsBiohazard Waste ManagementCLIA Proficiency TestingDonor Deferrals