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, federal requirements. The role focuses on compliance to training needs, SOPs, processes, and other regulatory or company directives to support operations and quality requirements. Responsibilities Report compliance status data to operational quality management. Collaborate with center management on 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. Perform final QA review and release for all shipment and associated documents to ensure they meet customer specifications. Maintain center records of QA reviews to ensure thoroughness, accuracy, and timeliness of required information. Initiate investigations and document regulatory deficiencies, determining the need for corrective action and ensuring its effectiveness. Maintain personnel training documents and ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements. Maintain the Learning Management System, ensuring data integrity, report generation, and data analysis to comply with company and regulatory standards. Schedule, coordinate, and monitor delivery of all training (new hire, annual, retraining) to meet center or other regulatory requirements and ensure the most current training materials are 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 investigations, document deficiencies, and develop corrective action plans. Identify and communicate non-conformities to CSL SOPs; conduct monthly quality team meetings to promote continuous process improvement in quality, safety, and training. Promote Safety, Health and Environment policies and procedures, ensuring training and practices are implemented and followed at the center. Conduct or lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other applicable regulations, developing center responses for deficiencies. Initiate, investigate, and close Trackwise reports in a timely manner, confirming corrective action effectiveness. Maintain a clean and efficient work environment, complying with all HSE and OSHA policies and procedures, and conduct routine internal audits as applicable. Follow all SOPs, company policies and procedures, and all 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, and understand policies associated with hyperimmune programs. Assist plasma center staff in completing other special projects or assignments as requested. Perform other job-related duties as assigned. Qualifications 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 in support of changing company objectives. Understanding of Quality Systems and/or regulated training requirements. Working Conditions Occasionally required to work with the public when they are dissatisfied. Approximately 80% standing and walking, 20% sitting. Requires reaching, bending, kneeling, and a high level of manual dexterity. Must see and speak with customers and observe equipment operation. Occasionally required to lift and carry 25 lbs. Exposure to hot and cold temperatures, sudden temperature changes, working with freezers, and various odors. Salary The expected base pay for this position at hiring is $23.04 per hour – $25.15 per hour. The actual base pay within this range is determined by qualifications, skill level, experience, competencies and other relevant factors. Benefits For more information on CSL Plasma benefits visit 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