Quality Specialist

CSL; Westland (MI); On-site; USD 75,000 - 110,000; Full time

Job summary

CSL is seeking a Quality Supervisor to monitor plasma center processes, ensure SOP and regulatory compliance, and maintain inspection readiness at all times. You will coordinate training and facilitate timely reporting of deviations to the FDA, while ensuring records quality and data integrity within the quality system.

You will lead internal audits, drive corrective actions, and oversee training materials and LMS maintenance in partnership with management and the broader quality organization.

Qualifications

• Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience
• 3-5 years’ experience in quality within Plasma or related industry
• Minimum 1-year supervisory/leadership experience or equivalent in a regulated environment
• Knowledge of cGMP, OHSA, FDA, and other applicable regulations

Responsibilities

• Under general direction, monitors plasma center processes to ensure SOP compliance and regulatory requirements
• Partners with management to keep the center inspection ready by managing compliance to SOPs and the quality system
• Ensures compliance to quality processes, regulatory requirements, SOPs and training for center operations
• Coordinates training and facilitates processes to support timely reporting of deviations to FDA
• Performs/ensures center records quality review for thoroughness, accuracy and timeliness
• Initiates investigations to document deficiencies and develop corrective action plans with management
• Ensures training materials are maintained; manages the Learning Management System data integrity
• Leads internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA and other regulations

Skills

Regulatory compliance

Process monitoring

Training coordination

Auditing

Quality awareness

Leadership

Education

Bachelor’s/Associate degree in business administration or biological sciences

Tools

Learning Management System

Job description

• Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
• Partners with management to have the center “inspection ready” at all times by managing compliance to SOPs and the quality system
• Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations
• Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA)
• Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information
• Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management
• Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis
• Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicableQualifications:
• Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience
• 3-5 years’ experience in quality within Plasma or related industry
• Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment
• Knowledge of cGMP, OHSA, FDA, and other applicable regulations
• Equivalent combination of education and professional work experience requiredDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.