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 and all applicable local, state, and federal requirements. The role ensures adherence to training needs, SOPs, processes, and other regulatory or company directives to support operations and quality requirements. You will report compliance status data to operational quality management, collaborate with center management on continuous improvement plans, and represent the center during internal and external audits, responding to questions and addressing quality concerns.

• Perform final QA review and release of all shipment documents to ensure compliance with customer specifications;
• Conduct center records QA review for thoroughness, accuracy, and timeliness;
• Initiate investigations, document regulatory deficiencies, and develop corrective action plans;
• Manage and review personnel training documents, maintain the Learning Management System, and ensure data integrity and regulatory compliance;
• Coordinate scheduling and delivery of all training (new hire, annual, retraining) and verify current training materials are used;
• Collaborate with center management to identify, coordinate, and deliver retraining addressing operational or quality issues;
• Conduct periodic process assessments and audits to ensure compliance with written procedures and identify non‑conformities;
• Lead monthly quality team meetings and internal audits, develop responses to deficiencies, and host external audits as needed;
• Ensure adherence to safety, health, and environmental policies; conduct safety training and maintain compliance;
• Maintain a clean and efficient work environment, comply with HSE and OSHA policies, and adhere to all applicable regulations (ADA, Civil Rights, EEOC, FDA, HIPAA, etc.);
• Maintain confidentiality of all personnel, donor, and center information, and understand policies related to hyperimmune programs if applicable;
• Assist plasma center staff with special projects and assignments as requested;
• Perform any 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 one‑year leadership experience or equivalent experience in a regulated environment;
• Strong customer service skills;
• Strong critical reasoning, decision‑making, and problem‑solving skills;
• Excellent organizational skills and attention to detail; ability to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities;
• Understanding of Quality Systems and/or regulated training requirements.

Occasionally required to work with the public when dissatisfied; 80% of time standing and walking, 20% sitting. Requires reaching, bending, kneeling, and manual dexterity. Ability to 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.

CSL Plasma operates one of the world’s largest and most sophisticated plasma donation networks with nearly 330 donation centers in the U.S. and Europe. Plasma collected at CSL Plasma facilities is used by CSL for manufacturing life‑saving plasma‑derived therapies.

Our benefits include comprehensive health, dental, vision, and other corporate benefits.

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 let us know. CSL Global Privacy Notice for Job Applicants and Candidates.