Quality Specialist

CSL • Mishawaka, IN

5d

About The Position

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

Requirements

• Must be able to work a flexible schedule including every other Saturday
• 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

Responsibilities

• 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

What This Job Offers

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