Quality Specialist

CSL Plasma•Buffalo, NY

About The Position

The Quality Specialist provides immediate support to the Assistant Manager of Quality by monitoring plasma center processes for compliance with CSL Operating Procedures and applicable local, state, and federal requirements. The role supports center operations and quality requirements by ensuring training, SOPs, processes, and regulatory or company directives are followed. It reports compliance-status data to operational quality management and collaborates with center management on continuous improvement plans. The specialist works with the Assistant Manager of Quality to represent the center during internal and external audits, respond to questions, and address quality concerns, including stopping operations or shipments when needed. The role also coordinates and manages center-level training activities, policies, and processes. This position reports to the Assistant Manager Quality. Responsibilities include reviewing and releasing shipments and associated documents; reviewing center records; investigating regulatory deficiencies and non-conformities; determining and documenting corrective actions and verifying their effectiveness; and maintaining personnel training documents and the Learning Management System. The specialist schedules and monitors required training, ensures current materials are used, and coordinates retraining to address operational or quality issues. The role conducts process assessments and internal audits, supports external audits, manages Trackwise reports, and promotes safety and environmental policies and practices. The position also requires maintaining a clean and efficient work environment, following SOPs and company policies, complying with applicable regulations, maintaining confidentiality of personnel, donor, and center information, and assisting with special projects or other assigned duties.

Requirements

High school diploma or equivalent.
At least one year of leadership experience or equivalent experience in a regulated environment.
Strong customer service skills.
Strong critical reasoning, decision-making, and problem-solving skills.
Organizational skills and attention to detail to manage multiple tasks, short deadlines, interruptions, and changing priorities.
Understanding of Quality Systems and/or regulated training requirements.

Nice To Haves

Associate or bachelor's degree in business administration or biological sciences.

Responsibilities

Perform final QA review and release of shipments and associated documents to ensure they meet customer specifications.
Review center records for thoroughness, accuracy, and timely completion; investigate and document regulatory deficiencies and non-conformities.
Determine, document, and follow up on corrective actions to confirm they are implemented and effective.
Maintain personnel training documents and the Learning Management System, including data integrity, reporting, and analysis.
Schedule, coordinate, and monitor new-hire, annual, and retraining activities, ensuring current training materials are used.
Conduct process assessments and internal audits, support external audits, and develop or coordinate responses to deficiencies.
Initiate, investigate, and close Trackwise reports in a timely manner.
Promote and ensure implementation of safety, health, and environmental policies and practices.
Collaborate with center management on continuous improvement and corrective or retraining plans.
Maintain confidentiality, follow applicable SOPs and regulations, and assist with special projects and other assigned duties.