Quality Specialist

CSL; Grand Blanc (MI); On-site; USD 80,000 - 110,000; Full time

Job summary

CSL Plasma in Grand Blanc, MI seeks a quality/compliance professional to monitor plasma center processes for SOPs and regulatory requirements, ensuring inspection readiness and adherence to the quality system.

You will coordinate training, support timely reporting of deviations to FDA, and lead internal audits to verify cGMP, OSHA, and other standards across the facility. Strong organizational and leadership skills are essential.

Qualifications

• Bachelor’s/Associate degree in business administration or biological sciences preferred.
• 3–5 years’ quality experience in plasma or related industry.
• Minimum 1-year supervisory/leadership experience or equivalent in a regulated environment.
• Knowledge of cGMP, OSHA, FDA, and other applicable regulations.
• Strong customer service skills.

Responsibilities

• Monitors plasma center processes to ensure compliance with SOPs 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 necessary training for plasma center and business operations.
• Coordinates training and facilitates processes to support timely reporting of biologic product deviations to FDA.
• Performs center records quality review to ensure thoroughness, accuracy and timeliness of required information.
• Initiates investigation to document deficiencies and develop corrective action plans with management.
• Maintains training materials/documents and the LMS for data integrity and reporting.
• Leads internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA, and other regulations.

Skills

Quality knowledge

Regulatory knowledge

Leadership

SOP compliance

Customer service

Education

Bachelor's/Associate in business or biosciences

Tools

LMS

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 applicable

Responsibilities

• 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 applicable

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 of 1-year experience in a regulated environment
• Knowledge of cGMP, OHSA, FDA, and other applicable regulations
• Strong customer service skills
• Equivalent combination of education and professional work experience required

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.