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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, including cGMP compliance, documentation review, and root-cause analysis. Capable of conducting effective training and maintaining high standards of donor safety and product quality.
Highest-signal resume keywords
CGMP ComplianceRoot-Cause AnalysisQuality AssuranceDonor Center Technician CertificationSOP 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 ControlDocumentation ReviewMathematics ProficiencyRegulatory UnderstandingTraining ObservationData AnalysisProblem-SolvingAttention to DetailEquipment InspectionRecord Keeping
Soft Skills
Interpersonal CommunicationOrganizational SkillsIntegrityCommitment to QualityFlexibility
Tools & Technologies
Computer Proficiency
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
FDA RegulationsSOPsQuality SystemsDonor SafetyPlasmapheresisAdverse-Event ReportingTraining RecordsQuality SpecificationsDonor EligibilityCorrective and Preventative Measures
About the role
Key responsibilities & impact- Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
- Complete weekly reviews of equipment QC and maintenance records
- Document, investigate and perform root-cause analysis for deviations and customer complaints related to product quality or donor safety
- Inspect and release incoming supplies
- Investigate and report supplies that do not meet quality specifications before use
- Perform documentation review for unsuitable test results
- Ensure cGMP regulations, SOPs and regulatory requirements are followed
- Perform all product release activities
- Review lookback information and documentation
- Review waste shipment documentation
- Review unexpected plasmapheresis events and related donor documentation
- Review electronic donor chart exceptions affecting donor eligibility, safety or product quality
- Review donor deferral notifications from competitor centers
- Review plasma processing documentation for proper freezing, storage and handling
- 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 preventative measures
- Communicate issues identified during reviews to the CQM
Requirements
What you’ll need- High school diploma or GED
- Obtains state licensures or certifications if applicable
- Typically requires no previous related experience
- Developing command of interpersonal communication, organizational and problem-solving skills
- Ability to understand FDA regulations
- Strong integrity and commitment to quality and compliance
- Good knowledge of mathematics
- Legible handwriting
- Proficiency with computers
- Ability to work flexible scheduling to meet business needs
- Ability to understand and follow SOPs and protocols
- Basic understanding of cGMP and quality systems
- Ability to spend hours sitting and reviewing documentation for accuracy
- Good organizational skills and attention to detail
- Certified and maintains certification as a Donor Center Technician
- Ability to meet the stated physical, environmental, visual, hearing and lifting demands of the role
Benefits
Comp & perks- Personal protective equipment required, including protective eyewear, garments, gloves and cold-gear