Plasma QA Specialist - Compliance & Quality Champion

KEDPLASMA LLC; Duncanville (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to help ensure donor safety and product quality in a regulated plasma center environment.

You will review documentation, support training, and participate in audits and continuous improvement initiatives to maintain compliance and data integrity. The role requires a life sciences degree with 1+ year in a regulated setting, strong data-analysis and documentation skills, and familiarity with FDA/EU GMP standards.

Qualifications

• Bachelor’s degree in life sciences or a related field preferred.
• Minimum 1 year of experience in a regulated industry.
• 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 elevate 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

Documentation

Regulatory compliance

Communication

Collaboration

Microsoft Office

Bloodborne pathogen safety

Education

Bachelor’s degree in life sciences or a related field

Job description

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to help ensure donor safety and product quality in a regulated plasma center environment.

You will review documentation, support training, and participate in audits and continuous improvement initiatives to maintain compliance and data integrity. The role requires a life sciences degree with 1+ year in a regulated setting, strong data-analysis and documentation skills, and familiarity with FDA/EU GMP standards.