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Posted: 10/20/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in quality assurance processes, compliance with cGMP regulations, and effective training methodologies. Capable of conducting thorough documentation reviews and root-cause analysis to ensure product quality and donor safety.
Highest-signal resume keywords
Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationInterpersonal Communication
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 with compliance to cGMP regulations, SOPs and regulatory requirements
- Perform all product release activities
- Review lookback information and documentation
- Review waste shipment documentation
- Review unexpected plasmapheresis events and related electronic donor chart documentation
- Review electronic donor chart exceptions affecting donor eligibility, donor safety or product quality
- 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 competency before independent work
- 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
- Review donor adverse-event reports and related documentation
- 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
- 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
- Must be certified and maintain 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 use required personal protective equipment
- Ability to perform frequent hand and foot movements, precise finger movements, bending, twisting, squatting and crouching as required
- Light lifting of 15 lbs., with a maximum lift of 50 lbs.
- Hearing acuity and correctable near and far vision
- Ability to communicate and understand spoken information
- Ability to work independently with little guidance
- Ability to perform a wide range of tasks under variable demands and changing conditions
- Ability to relate sensitive information to diverse groups
Benefits
Comp & perks- Personal protective equipment required, including protective eyewear, garments, gloves and cold-gear
- Equal employment opportunities and consideration consistent with applicable laws
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Documentation ReviewQuality ControlMathematics ProficiencySOP UnderstandingTraining ObservationData AnalysisProblem-SolvingEquipment InspectionRegulatory ComplianceQuality Systems Knowledge
Soft Skills
Organizational SkillsAttention to DetailIntegrityCommunication SkillsAdaptability
Tools & Technologies
Computer ProficiencyElectronic Donor Chart SystemsTraining Records Management
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
FDA RegulationsBiological Fluids SafetyPlasma ProcessingQuality SpecificationsCorrective and Preventive Measures