Quality Specialist

CSL Plasma • Rochester, NY

19d

About The Position

Under general direction, the Quality Specialist monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state, and federal requirements. The role partners with management to keep the center inspection-ready by managing compliance with SOPs and the quality system, and supports quality and regulatory processes, required training, and plasma center and business operations.

The position coordinates training and supports timely reporting of biologic product deviations to the FDA. It reviews center records for thoroughness, accuracy, and timeliness; initiates investigations to document deficiencies and develop corrective action plans in partnership with management; and maintains training materials and the Learning Management System, including data integrity, reporting, and analysis. The Quality Specialist also leads internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA, and other applicable regulations.

The expected base pay at hiring is $23.04–$25.15 per hour. Individual pay within this range depends on qualifications, skill level, experience, competencies, and other relevant factors. Different qualifications or responsibilities may apply based on local legal or educational requirements; local job documentation may apply.

Requirements

• 3–5 years of experience in quality within Plasma or a related industry.
• At least 1 year of supervisory or leadership experience, or the equivalent of 1 year of experience in a regulated environment.
• Knowledge of cGMP, OSHA, FDA, and other applicable regulations.
• Strong customer service skills.
• Equivalent combination of education and professional work experience required.

Nice To Haves

• Bachelor’s or associate degree in business administration or biological sciences preferred, or an equivalent combination of education, training, and experience.

Responsibilities

• Monitor plasma center processes for compliance with SOPs and applicable local, state, and federal requirements.
• Partner with management to maintain inspection readiness by managing compliance with SOPs and the quality system.
• Ensure compliance with quality processes, regulatory requirements, SOPs, and necessary training for plasma center and business operations.
• Coordinate training and facilitate processes supporting timely reporting of biologic product deviations to the FDA.
• Perform or ensure center records quality review for thoroughness, accuracy, and timely completion of required information.
• Initiate investigations to document deficiencies and develop corrective action plans in partnership with management.
• Maintain and regularly modify training materials and documents; maintain the Learning Management System to ensure data integrity, report generation, and data analysis.
• Lead internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA, and other applicable regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree