Hiring: Quality Specialist Company: CSL Location: Grand Blanc, MI Job Posted Time: 2026-09-10 14:20:08 About the job Experience: •3-5 years’ experience in quality within Plasma or related industry •5 years’ experience in quality within Plasma or related industry Required Skills: •Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements •Partners with management to have the center “inspection ready” at all times by managing compliance to SOPs and the quality system •Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations •Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA) •Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information •Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management •Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis •Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicable Qualifications: •Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience •Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment •Knowledge of cGMP, OHSA, FDA, and other applicable regulations Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!