Quality Assurance Specialist — Plasma Safety & Compliance

KEDPLASMA LLC; El Paso (TX); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Health & Wellness

Financial security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to uphold regulatory standards and ensure the safety and integrity of plasma products. You will work with QA leadership to monitor compliance, review records, and support training and audit readiness.

Join a team focused on donor safety, product quality, and continuous improvement in a highly regulated environment with exposure to bloodborne pathogens and cold storage areas.

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Qualifications

• Requires degree in life sciences or related field.
• 1 year in a regulated setting preferred (plasma center or biomedical).
• Strong data analysis and trend identification ability.
• Excellent written and verbal communication and collaboration.
• Familiarity with FDA, EU GMP, and cGMP standards.

Responsibilities

• Review manufacturing activities and documentation for SOP/regulatory compliance.
• Elevate non-compliance issues affecting donor safety or plasma quality.
• Support plasma release and shipment processes meeting specifications.
• Investigate deviations and assist corrective actions.
• Audit records for completeness, accuracy and data integrity.
• Monitor equipment qualification, calibration, and maintenance records.
• Ensure proper storage and documentation of supplies and equipment.
• Perform quality checks on stored/shipped products and reagents.
• Track quality data and identify improvement opportunities.
• Participate in internal audits and support external inspections.
• Assist training staff on quality procedures and maintain training records.
• Evaluate staff competency through observations and tests.
• Prepare epidemiological data and compliance reports.

Skills

Data analysis

Documentation

Communication

Regulatory standards

Microsoft Office

Education

Bachelor’s degree in life sciences or related field

Job description

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to uphold regulatory standards and ensure the safety and integrity of plasma products. You will work with QA leadership to monitor compliance, review records, and support training and audit readiness.

Join a team focused on donor safety, product quality, and continuous improvement in a highly regulated environment with exposure to bloodborne pathogens and cold storage areas.

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