Quality Assurance Specialist

KEDPLASMA; Chicago (IL); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health & Wellness benefits

Life insurance & AD&D

Paid time off & holidays

Training programs & development

Job summary

Kedrion Biopharma Inc. is seeking a detail-oriented Quality Assurance Specialist in Chicago to uphold regulatory standards and support continuous improvement across operations. You will work with QA leadership to review documentation, monitor compliance, and support training and audits.

The role involves ensuring donor safety, product quality, and readiness for inspections. Applicants should have a life sciences degree and experience in regulated environments.

Qualifications

• Bachelor's degree in life sciences or a related field.
• Experience in a regulated environment preferred (plasma center or biomedical).
• Strong data analysis and documentation skills.
• Familiarity with FDA, EU GMP, and cGMP standards.

Responsibilities

• Review manufacturing activities and documentation to ensure SOP and regulatory compliance.
• Identify non-compliance issues that could affect donor safety or plasma quality.
• Support plasma release and shipment processes ensuring units meet specs.
• Investigate deviations and assist in implementing corrective actions.
• Audit records for completeness 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 and 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 keep training records updated.
• Evaluate staff competency through observation, assessments, and proficiency testing.

Skills

Data analysis

Regulatory compliance

Documentation

Communication

Collaboration

Education

Bachelor's degree in life sciences

Tools

MS Office

Data entry systems

Job description

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.

Job Summary

Are you detail-oriented and passionate about quality and compliance? Join our team as a Quality Assurance Specialist and help ensure the safety and integrity of life-saving plasma products. In this role, you'll be a key player in upholding regulatory standards and supporting continuous improvement across the center's operations.

As a Quality Assurance Specialist, you'll work closely with the Quality Assurance Manager and center leadership to monitor compliance, review documentation, and support training and audit readiness. Your work will directly impact donor safety and product quality.

What You'll Do

• Review manufacturing activities and documentation to ensure compliance with SOPs and regulatory requirements.
• Identify and escalation 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.

Qualifications And Need-to-know

• 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.

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary ranges are determined based on relevant experience, education, and certifications.

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at [e-mail].

Employee Benefits:

• Health & Wellness - Full medical, dental, and vision coverage
• Financial Security - Life insurance, AD&D, and retirement savings plans
• Work-Life Balance - Paid time off, sick leave, and paid holidays
• Career Growth - Training programs and development opportunities
• Extra Perks - Employee discounts, wellness initiatives, and more!

For specific inquiries please reach out to us.

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.