.This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, and federal requirements. This role will ensure compliance with training needs, SOPs, processes, and other regulatory or company directives to support the operations and quality requirements for business operations.Reporting compliance status data to operational quality management.Collaborate with center management in the development and implementation of continuous improvement plans.Collaborate with the Assistant Manager of Quality (AMQ) to represent the center during internal and external audits, respond to questions, and may stop operations, including shipments, to address quality concerns.Responsible for coordinating and managing training activities, policies, and processes at the center level.The RolePerform final QA review and release for all shipments and associated documents to ensure shipments meet customer specifications.Ensure center records QA review for thoroughness, accuracy, and timeliness of required information. Initiate investigations and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation, and determine the effectiveness of the action.Maintain and review Plasma center personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation, and data analysis to comply with company and regulatory standards.Initiate, schedule, coordinate, and monitor the delivery of all training, such as new hire, annual, and any retraining, to meet center or other training and regulatory requirements.Collaborate with center management to identify, coordinate, and deliver retraining for correcting or improving operational or quality issues.Conduct periodic process assessments to ensure compliance with CSL written procedures. Initiate investigations to document deficiencies and develop corrective action plans, as necessary, in partnership with management.Identify and communicate non-conformities to CSL's SOPs. In the absence of the AQM, conduct monthly quality team meetings to inform, promote, assess, and identify opportunities for continuous process improvement in quality, safety, and training for implementation.Promote Safety, Health, and Environment Policies & Procedures. Ensure safety training and practices are implemented and followed within the center.Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA, and other regulations, as applicable, and develop center responses for deficiencies.Responsible for initiating, investigating, and closing Trackwise reports in a timely manner
