Plasma QA Specialist: Compliance & Quality

LFB; Florida; On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Health insurance?

Paid time off?

Job summary

LFB in Florida is seeking a Quality Assurance professional to perform donor record and equipment quality control reviews, as well as review medical reports and incidents. You will verify sample shipments and the release of incoming supplies, while initiating deviation reports as needed.

Under the QA Manager, you will ensure compliance with CLIA, cGMP, FDA SOPs, OSHA and internal procedures, and participate in root cause analyses for deviations and complaints affecting donor safety and product

Qualifications

• High school diploma, GED or equivalent required.
• Associate's degree preferred; 3–6 months quality or plasma industry experience required.

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 SOP Manual, CLIA, cGMP, OSHA, and internal company procedures.
• Reviews the documentation of unsuitable test results and the disposition of the associated units.
• 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
• Review lookback information
• Waste shipment review
• Initiates investigations and reports any supplies that have not met quality specifications and requirements before use
• Review medical incident reports and documentation

Education

Associate's degree preferred

3–6 months quality/plasma experience

Job description

LFB in Florida is seeking a Quality Assurance professional to perform donor record and equipment quality control reviews, as well as review medical reports and incidents. You will verify sample shipments and the release of incoming supplies, while initiating deviation reports as needed.

Under the QA Manager, you will ensure compliance with CLIA, cGMP, FDA SOPs, OSHA and internal procedures, and participate in root cause analyses for deviations and complaints affecting donor safety and product