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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in quality assurance processes, regulatory compliance, and training within a plasma center environment. Capable of conducting root-cause analysis, maintaining documentation accuracy, and ensuring adherence to cGMP and SOP standards.
Highest-signal resume keywords
Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationFDA Regulations Understanding
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 SystemsDocument ReviewMathematics ProficiencyTraining ObservationSOP UnderstandingProduct Release ActivitiesRoot-Cause AnalysisRegulatory ComplianceEmployee TrainingQuality Control
Soft Skills
Attention to DetailOrganizational SkillsProblem-Solving SkillsIntegrityCommitment to Quality
Tools & Technologies
Computer Proficiency
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
CGMPFDA RegulationsPlasma CenterQuality ControlSOP
About the role
Key responsibilities & impact- Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
- Review equipment QC and maintenance records weekly
- Document, investigate, and perform root-cause analysis for deviations and customer complaints related to product quality or donor safety
- Inspect and release incoming supplies and investigate supplies that do not meet quality specifications
- Review documentation for unsuitable test results
- Assist the Quality Systems Manager with cGMP, SOP, and regulatory compliance
- Perform product release activities
- Review lookback information, waste shipment documentation, plasmapheresis events, donor chart exceptions, donor deferral notifications, and plasma processing documentation
- Create, maintain, and audit training records and files
- Perform employee training observations to verify staff competency
- Conduct training for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations
- When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with internal donor center audits
- Review monthly trending reports and donor adverse event reports
- Conduct training addressing donor center corrective and preventive measures
- Communicate issues identified during reviews to the CQM
Requirements
What you’ll need- High school diploma or GED
- Typically requires no previous related experience
- Obtains state licensures or certifications if applicable
- Understanding of FDA regulations
- Basic understanding of cGMP and quality systems
- Ability to understand and follow SOPs and protocols
- Proficiency with computers
- Good knowledge of mathematics
- Ability to work flexible scheduling to meet business needs
- Strong integrity and commitment to quality and compliance
- Organizational, problem-solving, and attention-to-detail skills
- Ability to spend hours sitting and reviewing documentation for accuracy
- Ability to perform basic document review and employee observations
- Certified and maintains certification as a Donor Center Technician
- Ability to work in a plasma center with exposure to biological fluids, infectious organisms, electrical equipment, and extreme cold
- Ability to meet the stated physical, visual, hearing, lifting, and mobility demands
Benefits
Comp & perks- Equal employment opportunities and consideration consistent with applicable laws