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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in quality control processes, compliance with cGMP regulations, and effective communication skills. Capable of conducting thorough documentation reviews and training while maintaining high standards of quality and safety.
Highest-signal resume keywords
Quality ControlCGMP ComplianceDocumentation ReviewInterpersonal CommunicationDonor 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
Root-Cause AnalysisMathematics ProficiencyBasic Document ReviewQuality Systems UnderstandingEmployee Training Observation
Soft Skills
Organizational SkillsProblem-Solving SkillsIntegrityCommitment to QualityClear Communication
Tools & Technologies
SOPsQuality Management SystemsElectronic Donor Chart
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
FDA RegulationsPlasma CenterBiological FluidsInfectious OrganismsQuality Assurance
About the role
Key responsibilities & impact- 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 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, donor 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 competency
- Conduct training for center notifications, corporate directives, SOP changes, and initial SOP implementations
- 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 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 perform basic document review and employee observations
- Ability to understand and follow SOPs and protocols
- Ability to perform primary responsibilities of the Quality Associate role proficiently
- Basic understanding of cGMP and quality systems
- Ability to spend 4 to 6 hours per day sitting and reviewing documentation
- Ability to work independently with little guidance
- Ability to communicate information clearly and understand spoken instructions
- Ability to relate sensitive information to diverse groups
- Ability to lift 15 pounds, with a maximum lift of 50 pounds
- Ability to work in a plasma center with exposure to biological fluids, infectious organisms, electrical equipment, and temperatures below 32°F
- Donor Center Technician certification must be maintained
Benefits
Comp & perks- Personal protective equipment provided, including protective eyewear, garments, gloves, and cold-gear
- Equal employment opportunities and consideration consistent with applicable laws