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, 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 to 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
• Responsible for coordinating and managing training activities, policies and processes at the center level

You will report to the Assistant Manager Quality.

• Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.
• Ensure centre records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and documentation of regulatory deficiencies; determine the need for corrective action and verify its effectiveness.
• Maintain and review plasma centre 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 and retraining—to meet centre or other training and regulatory requirements, ensuring the most current training materials are used.
• Collaborate with centre management when reviewing 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 and develop corrective action plans in partnership with management.
• Identify and communicate non-conformities to CSL SOPs; in the absence of the AQM, conduct monthly quality team meetings to inform, promote and identify opportunities for continuous process improvement in quality, safety and training.
• Promote safety, health and environment policies and procedures; ensure safety training and practices are implemented and followed within the centre.
• Conduct or lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA and other applicable regulations; develop centre responses for deficiencies and host external audits when required.
• Initiate, investigate and close Trackwise reports in a timely manner; confirm through follow‑up that corrective action was implemented and effective.
• Maintain a clean and efficient work environment; comply with all HSE and OSHA policies and procedures; conduct routine internal procedure and documentation audits.
• Follow all SOPs, company policies and procedures.
• Comply with all local, state and federal regulations and laws, including but not limited to ADA, Civil Rights, EEOC, FDA, GHA, HIPAA and OSHA.
• Maintain confidentiality of all personnel, donor and centre information; understand policies and procedures associated with hyperimmune programs at the centre, if applicable.
• Assist centre staff in completing other special projects or assignments as requested.
• Perform 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 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 analyse situations.
• Organisational skills and attention to detail to handle multiple tasks, short deadlines,…