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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 root-cause analysis, documentation review, and compliance with cGMP regulations. Capable of conducting employee training and maintaining accurate training records while ensuring adherence to FDA regulations and organizational SOPs.
Highest-signal resume keywords
Quality AssuranceCGMP ComplianceRoot-Cause AnalysisDonor Center Technician CertificationFDA Regulations Knowledge
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 ProficiencySOP UnderstandingTraining Observation
Soft Skills
Interpersonal CommunicationOrganizational SkillsAttention to DetailProblem-Solving SkillsIntegrity
Tools & Technologies
Computer Proficiency
Certifications & Qualifications
Donor Center Technician Certification
Industry Keywords
CGMPFDA RegulationsQuality ComplianceDonor SafetyPlasma Processing
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; investigate and report supplies that do not meet quality specifications
- Review documentation 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, 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 required 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 review issues to the CQM
Requirements
What you’ll need- High school diploma or GED
- Obtains state licensures or certifications if applicable
- Knowledge 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
- Ability to spend hours sitting and reviewing documentation for accuracy
- Ability to perform basic document review and employee observations
- Ability to perform primary responsibilities of the Quality Associate role proficiently
- Certified and maintains certification as a Donor Center Technician
- Strong integrity and commitment to quality and compliance
- Developing interpersonal communication, organizational, and problem-solving skills
- Legible handwriting
- Demonstrates good organizational skills and attention to detail