Quality Specialist

The 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, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered to in order 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 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. You will report to the Assistant Manager Quality. The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. Ensure center records QA review for thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine 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. Ensure the most current version of training materials at the center is being used. Collaborate with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. Conduct periodic process assessments to ensure compliance with CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. Identify and communicate non-conformities to CSL’s SOPs. In the absence of the AQM, may 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 safety practices are implemented and followed within the center. Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. Responsible for initiating, investigating and closing Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. Maintain a clean and 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 to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with 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. Your 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 of one-year 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. Understand Quality Systems and/or regulated training requirements. Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied. 80% of the time standing and walking and 20% of the time sitting. Reach, bend, kneel and have a high level of manual dexterity. See and speak with customers and observe equipment operation. Occasionally be required to lift and carry 25 lbs. Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors. Our Benefits CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit . About CSL Plasma CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma . We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma! #J-18808-Ljbffr Initial Therapeutics, Inc.