Quality Specialist

About the Role

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 ensures compliance with training needs, SOPs, processes, and other regulatory or company directives to support operations and quality requirements for business operations.

• Report compliance status data to operational quality management
• Collaborate with center management in the development and implementation of continuous improvement plans
• 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

Responsibilities

• Perform final QA review and release for all shipments and associated documents to ensure they 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 and its 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 data analysis to comply with company and regulatory standards
• Initiate, schedule, coordinate, and monitor the 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 being used at the center
• 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 and develop corrective action plans as necessary
• Identify and communicate non-conformities to CSL’s SOPs
• In the absence of the Assistant Manager of Quality, conduct monthly quality team meetings to inform, promote, assess, and identify opportunities for continuous improvement
• Promote Safety, Health, and Environment Policies & Procedures; ensure safety training and practices are implemented and followed
• Conduct and may lead internal audits to monitor facility compliance with CSL procedures, cGMP, OSHA, FDA, and other regulations; develop center responses for deficiencies
• In the absence of the Assistant Manager of Quality, host external audits conducted by regulatory agencies and customers
• Initiate, investigate, and close Trackwise reports in a timely manner; confirm corrective actions are effective through follow-up
• Maintain a 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
• Follow all Standard Operating Procedures (SOPs), company policies, and procedures
• Comply with all local, state, and federal regulations and laws (e.g., ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, 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 with special projects or assignments as requested
• Perform other job-related duties as assigned

Requirements

• 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 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
• Understanding of Quality Systems and/or regulated training requirements

Working Conditions

• Occasionally required to work with the public when they are dissatisfied
• 80% of the time standing and walking; 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 required to lift and carry up to 25 lbs
• Exposure to hot and cold temperatures, sudden temperature changes, working with freezers, and various odors