Center Quality Specialist

LFB USA; Florence (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

LFB USA in Florence, SC seeks a Quality Assurance professional to perform donor record reviews, equipment QC, and review medical reports to ensure regulatory compliance and product safety.

In this role you will verify sample shipments, inspect incoming supplies, and participate in deviation management under CLIA, cGMP, and OSHA guidelines, with escalation to the Center QA Manager as needed.

Qualifications

• QA-focused experience in regulated environments.
• Knowledge of CLIA, cGMP, and FDA regulations.
• Familiarity with SOPs and quality systems.

Responsibilities

• Perform donor record file review.
• Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual.
• Review medical reports and communication.
• Perform reviews of equipment incidents.
• Verification and release of sample shipment.
• Responsible for the inspection and release of incoming supplies.
• Initiate deviation reports as needed.
• Perform Weekly employee observations.
• Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, CLIA, cGMP, OSHA, and internal company procedures.
• Reviews the documentation of unsuitable test results and the disposition of the associated units.
• In the absence of the Manager of Center Quality Assurance: conduct root cause analysis for deviations and customer complaints related to donor safety and product quality.
• Review equipment records and donor system information to approve out of service equipment for use.
• Review and approval of deferred donor reinstatement activities.

Skills

Quality Assurance

cGMP

CLIA

OSHA compliance

Regulatory knowledge

Documentation review

Job description

• Perform donor record file review
• Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
• Review medical reports and communication
• Perform reviews of equipment incidents
• Verification and release of sample shipment
• Responsible for the inspection and release of incoming supplies
• Initiate deviation reports as needed
• Perform Weekly employee observations
• Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
• Reviews the documentation of unsuitable test results and the disposition of the associated units

Essential Job Responsibilities And Duties

• Perform donor record file review
• Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
• Review medical reports and communication
• Perform reviews of equipment incidents
• Verification and release of sample shipment
• Responsible for the inspection and release of incoming supplies
• Initiate deviation reports as needed
• Perform Weekly employee observations
• Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
• Reviews the documentation of unsuitable test results and the disposition of the associated units

In the absence of the Manager of Center Quality Assurance:

• Conduct root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product
• Review of equipment records and donor system information, if applicable, to approve out of service equipment for use
• Review and approval of deferred donor reinstatement activities