Quality Assurance Specialist – Plasma Compliance & Impact

KEDPLASMA LLC; Chicago (IL); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Job summary

Kedplasma LLC in Chicago is seeking a Quality Assurance Specialist to help ensure safety and integrity of plasma products. You will review documentation, monitor compliance, and support training and audit readiness in a highly regulated environment.

The role involves coordinating with QA leadership, investigating deviations, and ensuring proper storage, handling, and testing of materials. Strong data analysis and communication skills are essential for success.

Qualifications

• Bachelor’s degree in life sciences or 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.
• Familiarity with FDA, EU GMP, and cGMP standards.
• Excellent communication and collaboration skills.
• Proficient in Microsoft Office and data entry systems.

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

Regulatory compliance

Data analysis

Documentation

Communication

Quality audits

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

Kedplasma LLC in Chicago is seeking a Quality Assurance Specialist to help ensure safety and integrity of plasma products. You will review documentation, monitor compliance, and support training and audit readiness in a highly regulated environment.

The role involves coordinating with QA leadership, investigating deviations, and ensuring proper storage, handling, and testing of materials. Strong data analysis and communication skills are essential for success.