Quality Specialist

CSL•Sacramento, CA

23h•$26 - $37

About The Position

The Quality Specialist provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes for compliance with CSL Operating Procedures and applicable local, state, and federal requirements. The role supports center operations by ensuring that training, standard operating procedures, processes, and other 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 Quality Specialist coordinates and manages center-level training activities, policies, and processes. The position performs quality reviews of shipments and center records, maintains personnel training records and the Learning Management System, investigates regulatory deficiencies and non-conformities, and determines and follows up on corrective actions. It conducts process assessments and internal audits, and may represent the center during internal or external audits, including responding to questions and stopping operations or shipments to address quality concerns. In the absence of the Assistant Manager of Quality, the Specialist may lead quality team meetings or host external audits. The role also promotes and monitors safety, health, and environmental policies and practices; maintains a clean and efficient work environment; protects confidential personnel, donor, and center information; and assists with special projects and other assigned duties. The job is non-exempt. Expected base pay at hiring is $26.33–$36.86 per hour, with individual pay determined by qualifications and other relevant factors.

Requirements

High school diploma or equivalent required.
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 shifting priorities.
Understanding of quality systems and/or regulated training requirements.
Ability to stand and walk for approximately 80% of the time and sit for approximately 20% of the time.
Ability to reach, bend, kneel, and perform work requiring a high level of manual dexterity.
Ability to see and speak with customers and observe equipment operation.
Ability to occasionally lift and carry up to 25 pounds.
Ability to work around hot and cold temperatures, sudden temperature changes, freezers, and various odors.
Ability to occasionally work with dissatisfied members of the public.

Nice To Haves

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

Responsibilities

Perform final quality assurance review and release of shipments and associated documents to ensure they meet customer specifications.
Review center records for thoroughness, accuracy, and timeliness; investigate and document regulatory deficiencies; determine corrective actions and assess their effectiveness.
Maintain and review personnel training documents and the Learning Management System for data integrity and compliance with company and regulatory requirements.
Schedule, coordinate, and monitor new-hire, annual, and retraining activities, ensuring current training materials are used.
Work with center management to identify, coordinate, and deliver retraining to address operational or quality issues.
Conduct periodic process assessments and internal audits; document deficiencies and develop corrective action plans with management as needed.
Identify and communicate non-conformities; initiate, investigate, and close Trackwise reports and follow up to confirm corrective actions are implemented and effective.
Support or represent the center during internal and external audits; develop responses to deficiencies and, when necessary, stop operations or shipments to address quality concerns.
Promote and monitor safety, health, and environmental policies and practices, including required safety training and center practices.
Maintain a clean, efficient work environment; follow company procedures and applicable regulations; protect confidential information.
Assist plasma center staff with special projects or assignments and perform other job-related duties as assigned.