The Center Quality Specialist is responsible for performing quality control reviews and ensuring compliance with state, federal, and FDA regulations
Job Summary
The Center Quality Specialist is responsible for performing quality control reviews and ensuring compliance with state, federal, and FDA regulations.
This role involves conducting root cause analysis, reviewing medical incidents, and assisting the Quality Assurance Manager in maintaining high standards of product and donor safety.
Physical requirements include manual dexterity, ability to stand for extended periods, and lifting up to fifty pounds.
Matching Summary
The Center Quality Specialist is responsible for performing quality control reviews and ensuring compliance with state, federal, and FDA regulations.
Skills & Requirements
Must-have
Donor record file review
Equipment quality control review
Compliance with FDA and CLIA regulations
Deviation report initiation
Sample shipment verification and release
Employee observation and documentation
Analytical and organizational skills
Nice-to-have
Problem-solving and decision-making abilities
Proficiency with computers
Attention to detail
Ability to interpret technical instructions
Manual dexterity in donor plasmapheresis
Key Requirements
High school diploma or GED required
Associates degree preferred
3 to 6 months quality or plasma industry experience