Quality Specialist

Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures and all applicable local, state, federal requirements. The role will ensure compliance with training needs, SOPs, processes and other regulatory or company directives to support 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 Assistant Manager of Quality 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 Role Perform final QA review and release for all shipments and associated documents, ensuring shipment meets customer specifications Ensure center records QA review for thoroughness, accuracy, and timeliness of required information; initiate investigations and document regulatory deficiencies; determine need for corrective action and assess effectiveness 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 analysis in compliance with company and regulatory standards Initiate schedule, coordinate and monitor delivery of all training (new hire, annual, retraining) to meet center and regulatory requirements; ensure current training materials are used Collaborate with center management when reviewing the Quality Management System to identify, coordinate and deliver retraining for corrective or improvement purposes Conduct periodic process assessments to ensure compliance with CSL written procedures; initiate investigations and develop corrective action plans as necessary in partnership with management Identify and communicate non-conformities to CSL’s SOPs; conduct monthly quality team meetings to promote continuous process improvement when AQM is absent 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; develop center responses for deficiencies; host external audits when AQM is absent Initiate, investigate and close Trackwise reports in a timely manner; confirm through follow-up that corrective action was implemented and effective Maintain a clean, efficient work environment; comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures; conduct routine internal procedure and documentation audits as applicable Follow all Standard Operating Procedures (SOPs), company policies and procedures Comply with all local, state and federal regulations and laws, including ADA, Civil Rights, EEOC, FDA, HIPAA, OSHA Maintain confidentiality of all personnel, donor and center information; understand policies and procedures related to hyperimmune programs at the center, if applicable Assist Plasma center staff in completing other special projects or assignments as requested Perform other job-related duties as assigned (4-6 key responsibilities) Skills and Experience Education High school diploma or equivalent required Associate or Bachelor’s degree in business administration or biological sciences preferred Experience Minimum 1-year leadership experience or equivalent experience in a regulated environment Strong customer service skills Strong critical reasoning, decision‑making and problem‑solving skills to analyze situations Organizational skills and attention to detail to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives Understanding of Quality Systems and/or regulated training requirements Working Conditions Occasionally required to work with the public when dissatisfied 80% time standing and walking, 20% sitting Reach, bend, kneel and possess high manual dexterity See and speak with customers and observe equipment operation Occasionally required to lift and carry 25 lbs Exposure to hot and cold temperatures, sudden temperature changes, work with freezers and various odors Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit #J-18808-Ljbffr CSL