Quality Assurance Specialist – Regulated Life Sciences

Kedrion Biopharma GmbH; El Paso (TX); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health insurance

Dental & Vision coverage

Paid time off & holidays

Career growth & training

Employee discounts

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist in El Paso, Texas, to uphold regulatory standards and ensure the safety and integrity of plasma-derived products. You will review manufacturing activities and support root cause investigations.

You will assist in training, audits, and documentation control, while maintaining data integrity and collaboration with the QA Manager and center leadership in a highly regulated environment.

Qualifications

• Bachelor’s degree in life sciences or a related field preferred.
• Minimum 1 year of experience in a regulated industry (plasma center or biomedical field preferred).
• Ability to analyze data and identify trends.
• Strong organizational and documentation skills.
• Familiarity with FDA, EU GMP, and cGMP standards.
• Excellent communication and collaboration skills.
• Comfortable working in a highly regulated environment with exposure to bloodborne pathogens and cold storage areas.
• Proficiency in Microsoft Office and data entry systems preferred.

Responsibilities

• Review manufacturing activities and documentation to ensure compliance with SOPs and regulatory requirements.
• Identify and escalate non-compliance issues that could affect donor safety or plasma quality.
• Support plasma release and shipment processes, ensuring all units meet specifications.
• Investigate deviations and assist in implementing corrective actions.
• Audit records for completeness, consistency, and accuracy to maintain data integrity.
• Monitor equipment qualification, calibration, and maintenance documentation.
• Ensure proper storage and documentation of supplies, reagents, and equipment.
• Perform quality control checks on stored and shipped products, as well as test reagents.
• Track and trend quality data to identify improvement opportunities.
• Participate in internal audits and support external inspections.
• Assist in training staff on quality procedures and ensure training records are up to date.
• Evaluate staff competency through direct observation, written assessments, and proficiency testing.
• Prepare and submit epidemiological data and compliance reports as required.
• Promote a culture of continuous improvement and regulatory excellence.

Skills

Data analysis

Regulatory compliance

Documentation

Communication

Education

Bachelor’s degree in life sciences or related field

Tools

Microsoft Office

Data entry systems

Job description

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist in El Paso, Texas, to uphold regulatory standards and ensure the safety and integrity of plasma-derived products. You will review manufacturing activities and support root cause investigations.

You will assist in training, audits, and documentation control, while maintaining data integrity and collaboration with the QA Manager and center leadership in a highly regulated environment.