Quality Assurance Specialist

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc., specializing in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company focused on 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.

About the role

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 uphold regulatory standards and support continuous improvement across the center’s operations. 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.

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.

Requirements

• 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.

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