Quality Specialist

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 Responsibilities 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 3-5 years’ experience in quality within Plasma or related industry 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 Strong customer service skills Equivalent combination of education and professional work experience required Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. #J-18808-Ljbffr