Katie Russell

• Executed 5-6 on-site audits each year at BioLife centers throughout the network for the Plasma Quality Assessment Group (PQAG), while managing the Grand Forks BioLife Quality Department.
• Executed comprehensive desk assessments prior to two-day on-site audit activities.
• Reviewed documentation for accuracy and completeness during audits.
• Detected discrepancies through comprehensive analysis of records.
• Assembled preliminary reports detailing audit findings, and distributed reports promptly to the PQAG team for peer review post-audit.

• Evaluated all operational records to verify completeness, accuracy, and compliance with cGMP requirements.
• Maintains center compliance with federal, state, local, and company-specific regulations regarding product quality, employee safety, and donor safety.
• Verifies SOP currency and oversees staff adherence to routine tasks via direct observation.
• Tracked deviations and trends in operational procedures using established reporting mechanisms.
• Communicated errors, deficiencies, and discrepancies to center management and Regional Quality Manager.
• Analyzed observations and investigations using DMAIC tools to enhance compliance with quality standards.
• Managed periodic inspections in collaboration with regulatory agencies like EMA, FDA, CLIA, PPTA
• Facilitated employee development and delivered constructive feedback within quality department.
• Delivers feedback throughout recruitment process for quality department personnel, encompassing performance evaluations and merit increases.

Various roles are held within the center involving the plasma collection process, donor screening, and sample processing, such as:

• Medical Historian
• Plasma Center Technician (PCT)
• Senior PCT
• Advanced PCT
• Lead Technician

Designated as Quality Lead Technician (QLT) in 2011, enabling QA training and assisting Quality Manager with comprehensive quality tasks while continuing operational duties.