Center Quality Assurance Specialist

LFB Biopharmaceuticals; Anniston (AL); On-site; USD 45,000 - 65,000; Full time

Job summary

LFB Biopharmaceuticals in Anniston, AL, is hiring a Quality Assurance professional to perform donor record and equipment QC reviews, inspect incoming supplies, and release samples. The role includes deviation investigations, root cause analysis, and adherence to FDA/cGMP, CLIA, OSHA, and internal SOPs.

Strong analytical and communication skills are essential for this hands-on position. Responsibilities cover medical report review, incident investigations, and weekly observations, with emphasis

Qualifications

• High school diploma, GED or equivalent required. Associates degree preferred.
• 3–6 months quality or plasma industry experience required.
• Strong verbal and written communication skills; attention to detail.

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 procedures.
• Reviews the documentation of unsuitable test results and the disposition of the associated units.
• In the absence of the Manager: 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 approve deferred donor reinstatement activities.
• Review lookback information and waste shipment reviews.
• Initiates investigations and reports any supplies that do not meet quality specs before use.

Skills

Verbal communication

Written communication

Analytical thinking

Attention to detail

Problem solving

Organization

Follow-up

Reading comprehension

Education

High school diploma or GED

Associates degree preferred

Tools

Computer proficiency

Job description

LFB Biopharmaceuticals in Anniston, AL, is hiring a Quality Assurance professional to perform donor record and equipment QC reviews, inspect incoming supplies, and release samples. The role includes deviation investigations, root cause analysis, and adherence to FDA/cGMP, CLIA, OSHA, and internal SOPs.

Strong analytical and communication skills are essential for this hands-on position. Responsibilities cover medical report review, incident investigations, and weekly observations, with emphasis