Quality Specialist

Overview

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
• Coordinate and manage training activities, policies and processes at the center level

The Opportunity (duplicate section removed to maintain clarity)

• Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications
• Ensure center records QA review to ensure 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 documents comply 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 (new hire, annual and 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 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
• Identify and communicate non-conformities to CSL’s SOPs; in the absence of the AQM, may conduct monthly quality team meetings to promote continuous process improvement in quality, safety, and training
• Promote Safety, Health and Environment Policies & Procedures; ensure safety training and safety practices are implemented and followed
• Conduct 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 in the absence of the AQM
• Initiate, investigate and close Trackwise reports in a timely manner; follow up to ensure corrective action is initiated, implemented, and effective
• Maintain a clean, efficient work environment; comply with Health, Safety and Environmental (HSE) and OSHA policies and procedures; conduct routine internal audits
• Follow all SOPs, company policies and procedures; comply with local, state and federal regulations including ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, OSHA
• Maintain confidentiality of all personnel, donor and center information; understand policies 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

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 in a regulated environment
• Strong customer service skills
• Strong critical reasoning, decision-making and problem solving skills
• Organizational skills and attention to detail to handle multiple tasks and shifting priorities
• Understanding of Quality Systems and/or…