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, as well as all applicable local, state, and federal requirements. The role ensures compliance with training needs, SOPs, processes, and regulatory directives to support operations and quality requirements for business operations. You will report to the Assistant Manager of Quality. Responsibilities Reporting 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, responding to questions and, when necessary, stopping operations or shipments to address quality concerns Coordinate and manage training activities, policies, and processes at the center level Perform final QA review and release for all shipments and associated documents to ensure shipment meets customer specifications Ensure thoroughness, accuracy, and timeliness of required information in center records QA reviews, initiate investigations, document regulatory deficiencies, determine the need for corrective action, and confirm 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 in compliance with company and regulatory standards Initiate, coordinate, and monitor the delivery of all training—including new hire, annual, and retraining—to meet center or other training and regulatory requirements Collaborate with center management to identify, coordinate, and deliver retraining to correct or improve operational or quality issues Conduct periodic process assessments to verify compliance of CSL written procedures, investigate deficiencies, and develop corrective action plans in partnership with management Identify and communicate non-conformities to CSL’s SOPs and conduct monthly quality team meetings to promote continuous process improvement in quality, safety, and training when the Assistant Manager of Quality is absent Promote Safety, Health and Environment Policies & Procedures, ensuring safety training and practices are implemented and followed within the center Conduct and, when necessary, lead internal audits to monitor facility compliance with CSL procedures, cGMP, OSHA, FDA, and other regulations; develop responses for deficiencies and host external audits when the Assistant Manager of Quality is absent Initiate, investigate, and close Trackwise reports in a timely manner, following up to confirm corrective actions were implemented and effective Maintain a clean, efficient work environment and comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures, conducting routine internal procedural and documentation audits as applicable Follow all Standard Operating Procedures (SOPs) and company policies and procedures Comply with all relevant local, state, and federal regulations and laws, including 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 with special projects or assignments as requested 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 regulated environment experience 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 dissatisfied public 80% of the time standing and walking; 20% of the time sitting Reach, bend, kneel and have high 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 Compensation The expected base pay for this position at hiring is $23.04/hour - $25.15/hour. Individual base pay within this range is determined by qualifications, skill level, experience, competencies and other relevant factors. 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