Plasma Quality Assurance & Compliance Specialist

Kedrion Biopharma GmbH; Duncanville (TX); Hybrid; USD 55,000 - 85,000; Full time

Benefits offered by this job

Health & Wellness – Medical, dental, &

Financial Security – Life insurance &

Work-Life Balance – PTO, sick leave, &

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to uphold regulatory standards and support continuous improvement.

You will monitor compliance, review documentation, and assist in training and audit readiness, directly impacting donor safety and product quality. In collaboration with the Quality Assurance Manager and center leadership, you will identify deviations, implement corrective actions, and support inspections.

Qualifications

• Bachelor’s degree preferred in life sciences or related field.
• 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.

Responsibilities

• Review activities and documentation for SOP and regulatory compliance.
• Identify and elevate non-compliance issues affecting donor safety or plasma quality.
• Support plasma release and shipment processes to ensure specs are met.
• Investigate deviations and assist in corrective actions.
• Audit records for completeness, consistency, and accuracy.
• Monitor equipment qualification, calibration, and maintenance docs.
• Ensure proper storage and documentation of supplies and equipment.
• Perform quality control checks on products and test reagents.
• Track and trend quality data to identify improvements.
• Participate in internal audits and support external inspections.
• Assist in training staff on quality procedures and maintain training records.
• Evaluate staff competency through observation and assessments.
• Prepare and submit epidemiological data and compliance reports.
• Promote continuous improvement and regulatory excellence.

Skills

Data analysis

Organizational skills

Communication skills

Regulatory knowledge

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 to uphold regulatory standards and support continuous improvement.

You will monitor compliance, review documentation, and assist in training and audit readiness, directly impacting donor safety and product quality. In collaboration with the Quality Assurance Manager and center leadership, you will identify deviations, implement corrective actions, and support inspections.