Center Quality Assurance Specialist

LFB Biopharmaceuticals; Anniston (AL); In loco; USD 42.000 - 64.000; Tempo pieno

Descrizione del lavoro

LFB Biopharmaceuticals in Anniston, Alabama is seeking a Quality Assurance associate responsible for donor record reviews, equipment QC reviews, and reviewing medical reports to ensure compliance with CLIA, FDA cGMP, OSHA and internal SOPs.

The role requires attention to detail, strong problem-solving, computer proficiency, and the ability to interpret safety rules and complex procedures. Join a team dedicated to quality and patient safety in a plasma-derived product environment.

Competenze

• Strong verbal and written communication skills.
• Above-average problem-solving and decision-making abilities.
• Proficiency with computers.
• Explicit attention to detail.
• Excellent analytical, organizational and follow-up skills.
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedures.
• Ability to interpret complex technical instructions.

Mansioni

• 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 SOPs, CLIA, cGMP, OSHA, and internal procedures.
• Review documentation of unsuitable test results and disposition of units.
• Conduct root cause analysis for deviations and customer complaints related to safety and product quality.
• Review equipment records and donor system information to approve out-of-service equipment.
• Review and approve deferred donor reinstatement activities.
• Review lookback information and waste shipment reviews.
• Initiate investigations and report supplies not meeting quality specs.
• Review medical incident reports and documentation.

Conoscenze

Strong verbal communication skills

Strong written communication skills

Attention to detail

Problem-solving and decision-making

Proficiency with computers

Analytical and organizational skills

Formazione

High school diploma or GED

Associates degree preferred

Strumenti

Computers

Descrizione del lavoro

LFB Biopharmaceuticals in Anniston, Alabama is seeking a Quality Assurance associate responsible for donor record reviews, equipment QC reviews, and reviewing medical reports to ensure compliance with CLIA, FDA cGMP, OSHA and internal SOPs.

The role requires attention to detail, strong problem-solving, computer proficiency, and the ability to interpret safety rules and complex procedures. Join a team dedicated to quality and patient safety in a plasma-derived product environment.