Center Quality Assurance Specialist - Plasma

Lfb USA; Anniston (AL); On-site; USD 42,000 - 65,000; Full time

Job summary

Lfb USA in Anniston, AL is seeking a Quality Assurance Associate to perform donor record file reviews, equipment quality control reviews, and review medical reports and communications.

You will assist with compliance to FDA/CLIA/cGMP/OSHA standards, investigate deviations, review equipment records, and participate in root-cause analysis. Strong detail orientation and computer proficiency are required.

Qualifications

• High school diploma or GED required; associates degree preferred.
• 3–6 months quality or plasma industry experience is a plus.
• Strong communication and attention to detail are essential.

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, 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.
• 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.

Skills

Verbal communication

Written communication

Attention to detail

Problem solving

Proficiency with computers

Analytical skills

Organizational skills

Follow-up

Education

High school diploma or GED

Associates degree preferred or 3-6 months quality or plasma industry experience

Job description

Lfb USA in Anniston, AL is seeking a Quality Assurance Associate to perform donor record file reviews, equipment quality control reviews, and review medical reports and communications.

You will assist with compliance to FDA/CLIA/cGMP/OSHA standards, investigate deviations, review equipment records, and participate in root-cause analysis. Strong detail orientation and computer proficiency are required.