Quality Specialist

CSL • Citrus Heights, CA

11d • $26 - $37

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 operational and quality requirements by ensuring training, SOPs, 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. In partnership with the Assistant Manager of Quality, the specialist may represent the center during internal and external audits, respond to questions, and stop operations or shipments to address quality concerns. The position coordinates and manages center-level training activities, policies, and processes.

The specialist performs quality reviews and releases of shipments and associated documents, reviews center records, investigates regulatory deficiencies, and determines and follows up on corrective actions. The role maintains personnel training documents and the Learning Management System, coordinates required training, assesses processes for compliance, and supports retraining and continuous improvement. It also conducts or leads internal audits, may host external audits in the Assistant Manager of Quality’s absence, and initiates, investigates, and closes Trackwise reports. The position promotes safety, health, and environmental policies; maintains a clean and efficient work environment; follows applicable procedures and regulations; protects confidential information; and assists with special projects and other assigned duties.

The role is non-exempt. The expected base pay at hiring is $26.33–$36.86 per hour; individual pay depends on qualifications, skills, experience, competencies, and other relevant factors. Physical working conditions include standing and walking about 80% of the time and sitting about 20%, occasional interaction with dissatisfied members of the public, reaching, bending, kneeling, manual dexterity, seeing and speaking with customers, observing equipment, occasional lifting and carrying up to 25 pounds, and exposure to hot and cold temperatures, sudden temperature changes, freezers, and various odors.

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 changing priorities.
• Understanding of Quality Systems and/or regulated training requirements.
• Ability to meet the stated physical and environmental working conditions, including standing and walking, reaching, bending, kneeling, manual dexterity, occasional lifting and carrying up to 25 pounds, and exposure to temperature changes, freezers, and odors.

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 customer specifications are met.
• Review center records for thoroughness, accuracy, and timeliness; investigate regulatory deficiencies and determine, document, and verify the effectiveness of corrective actions.
• Maintain and review personnel training documents and the Learning Management System for compliance, data integrity, reporting, and analysis.
• Schedule, coordinate, and monitor required training, including new-hire, annual, and retraining activities, and ensure current training materials are used.
• Conduct periodic process assessments and internal audits; identify deficiencies, develop corrective action plans with management, and prepare or support audit responses.
• Initiate, investigate, and close Trackwise reports in a timely manner, confirming corrective actions were implemented and effective.
• Collaborate with center management and the Assistant Manager of Quality on compliance reporting, continuous improvement, and operational or quality retraining.
• Promote and monitor compliance with safety, health, and environmental policies and practices.
• Maintain a clean and efficient work environment, protect confidential information, follow SOPs and company policies, and assist with special projects or other assigned duties.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED