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 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

• 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 need for corrective action, ensure appropriate documentation and determine effectiveness of 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 delivery of all training (new hire, annual, retraining) to meet center or other training and regulatory requirements; ensure the most current version of training materials is 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 of CSL written procedures; initiate investigation, document deficiencies and develop corrective action plans as necessary in partnership with management
• Identify and communicate non-conformities to CSL’s SOPs; when the AQM is absent, 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 & Procedure; 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; develop center responses for deficiencies; when the AQM is absent, host external audits conducted by the regulatory agencies and customers
• Initiate, investigate and close Trackwise reports in a timely manner; confirm through follow-up to ensure appropriate corrective action was initiated, implemented and effective
• Maintain clean and efficient work environment; comply with all Health Safety and Environmental (HSE) and 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

• High school diploma or equivalent required
• Associate or Bachelor’s degree in business administration or biological sciences preferred

• Minimum 1-year leadership experience or equivalent of one year experience in a regulated…