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Posted: 10/20/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management systems, regulatory compliance, and corrective actions within a plasma donor center environment. Proficient in root cause analysis, training oversight, and maintaining high standards of donor safety and product quality.
Highest-signal resume keywords
Quality Management SystemsRegulatory ComplianceRoot Cause AnalysisCGMP ExperienceFDA Regulations
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 ensure continuous quality improvement
- Direct and monitor processes for compliance with state, federal, and company regulations
- Implement SOPs for quality control and regulatory compliance
- Oversee the center training program, audit training records, and ensure staff competency
- 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, scheduling, and follow-up
- Oversee internal and external audits, 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 assess the effectiveness of corrective/preventive actions and process improvement plans
- Oversee product and biohazard waste shipments, including 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
- Perform employee training observations before independent work release
- Ensure supplies and materials meet quality requirements and are properly stored; initiate investigations or rejection for non-conformance
- 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 status updates and manage action outcomes
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the 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
- Full command of mathematics
- High level of proficiency with computers
- Proficiency in root cause analysis and corrective/preventative actions
- Ability to balance multiple competing priorities
- Strong time management abilities
- Ability to maintain a high level of quality and compliance
- Ability to work with minimal supervision
- Ability to travel when needed for meetings, events, and occasional support of other centers
- 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 sit for 6–8 hours per day
- Ability to lift and carry up to 35 lbs
- Ability to drive to site locations and travel occasionally within the United States
- Ability to communicate complex information and obtain consensus with diverse groups
Benefits
Comp & perks- Medical benefits
- PTO
- Up to 5% 401(k) match
- Tuition reimbursement
- Opportunities for professional growth and career progression
- Family-like culture
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 ActionsProcess ImprovementData AnalysisSOP ImplementationTraining Program OversightAudit ManagementMathematics ProficiencyDocumentation SkillsDonor Suitability Assessment
Soft Skills
Time ManagementCommunication SkillsProblem-SolvingCollaborationAdaptability
Tools & Technologies
Quality Analysis SoftwareTraining Management SystemsCompliance Tracking Tools
Certifications & Qualifications
Bachelor of Science Degree
Industry Keywords
Plasma DonationCGMP RegulationsFDA ComplianceBiological SafetyQuality Improvement