What are the responsibilities and job description for the Quality Compliance Auditor position at KEDPLASMA?
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
Drive Quality. Strengthen Compliance. Shape a Safer Future.
Join us as a Compliance Auditor, where you’ll play a critical role in ensuring regulatory excellence across internal and external plasma centers, laboratories, and suppliers. This role supports audit planning, execution, and follow up while helping safeguard product quality and regulatory compliance.
What You'll Do
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 kedtalent@kedrion.com.
Employee Benefits: At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:
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.
Job Summary
Drive Quality. Strengthen Compliance. Shape a Safer Future.
Join us as a Compliance Auditor, where you’ll play a critical role in ensuring regulatory excellence across internal and external plasma centers, laboratories, and suppliers. This role supports audit planning, execution, and follow up while helping safeguard product quality and regulatory compliance.
What You'll Do
- Assist in developing the audit schedule for KEDPLASMA.
- Verify the compliant collection of Quality Source Plasma.
- Participate in the Audit Peer Review Panel, offering recommendations.
- Coordinate, schedule, participate in, and/or perform on site internal cGMP and GLP compliance audits for centers, labs, and warehouse facilities.
- Host audits as the key quality representative for European Medicines Agency and customer audits.
- Lead center review of findings, corrective action coordination (CAPA), and audit closure.
- Prepare audit reports and assign compliance levels based on established criteria.
- Create trend and summary reports highlighting audit observations.
- Evaluate and approve audit responses to minimize risk.
- Participate in corrective action processes and verify implementation.
- Analyze audit and performance data to assess risks associated with new and existing suppliers.
- Recommend acceptance or rejection of suppliers.
- Identify gaps in internal procedures and recommend process improvements.
- Lead and ensure timely completion of supplier audits.
- Write and revise procedures related to audits, supplier approval, and the KEDPLASMA Logistics System (KLS).
- Support training for internal and third-party contract auditors.
- Collaborate across departments on compliance related activities.
- Uphold company policies, Global Code of Conduct, safety practices, attendance expectations, and professionalism standards.
- Maintain a positive, safe, respectful environment for colleagues, visitors, and donors.
- Perform additional duties as assigned.
- Bachelor’s degree (BS/BA) or 4–8 years of experience in a plasma center or auditing.
- Experience preparing for and participating in regulatory audits.
- Comprehensive knowledge of FDA and EMA standards.
- Strong understanding of cGMP, quality systems, and compliance in biological manufacturing or plasma/blood collection.
- Travel up to 90% to plasma centers and other KEDPLASMA/Kedrion locations (overnight travel included).
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 kedtalent@kedrion.com.
Employee Benefits: At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:
- 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!
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.