Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
Job Summary
Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements.
Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA).
CSL Plasma operates one of the world’s largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe.
Matching Summary
Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements.
Skills & Requirements
Must-have
ensure compliance with SOPs
manage compliance to quality system
cGMP, OHSA, FDA regulations
biologic product deviations reporting
internal audits
maintain Learning Management System
Nice-to-have
strong customer service skills
foster strong relationships
culture of curiosity and empathy
Key Requirements
3-5 years' experience in quality
Minimum 1-year supervisory/leadership experience
Bachelor’s/Associate degree preferred
Equivalent combination of education and experience