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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 regulations and SOP adherence, while effectively conducting training and documentation reviews. Capable of performing root-cause analysis and maintaining compliance with FDA regulations and quality systems.
Highest-signal resume keywords
Quality AssuranceCGMP RegulationsSOP AdherenceRoot-Cause AnalysisDonor Center Technician Certification
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 ProficiencyRoot-Cause AnalysisTraining ObservationBiological Fluid HandlingRegulatory ComplianceData AnalysisEquipment InspectionProduct Release Activities
Soft Skills
Organizational SkillsAttention to DetailCommunication SkillsIndependent WorkFlexibility
Tools & Technologies
Laboratory EquipmentOffice EquipmentElectronic Donor Chart Systems
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
FDA RegulationsCGMPSOPsQuality SystemsDonor SafetyPlasmapheresisAdverse Event ReportingTraining RecordsInternal AuditsQuality Specifications
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
- Perform documentation reviews for unsuitable test results
- Assist the Quality Systems Manager in ensuring 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 electronic donor chart exceptions
- Review donor deferral notifications from competitor centers
- Review plasma processing documentation for 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
- Occasionally review and approve deferred donor reinstatement activities when the Quality Systems Manager is absent
- Assist with internal donor center audits
- Review monthly trending reports and donor adverse event reports
- Conduct training addressing donor center corrective and preventative measures
Requirements
What you’ll need- High school diploma or GED
- Obtains state licensures or certifications if applicable
- Ability to understand FDA regulations
- Good knowledge of mathematics
- 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
- Organizational skills and attention to detail
- Certified and maintains certification as a Donor Center Technician
- Exposure to biological fluids, electrical office and laboratory equipment, and extreme cold below 32°F
- Ability to lift 15 lbs., with a maximum lift of 50 lbs.
- Hearing acuity essential; correctable near and far vision requirements
- Ability to communicate information, listen, understand spoken information, and work independently
- Typically requires no previous related experience
Benefits
Comp & perks- Regular full-time employment
- Equal employment opportunities and consideration under applicable laws