Quality Assurance Specialist

About the role

KEDPLASMA, a subsidiary of Kedrion Biopharma Inc., specializes in collecting and processing high‑quality plasma into life‑saving therapies. The Quality Assurance Specialist will work closely with the Quality Assurance Manager and center leadership to monitor compliance, review documentation, and support training and audit readiness, directly impacting 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.

Qualifications

• 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

• Full medical, dental, and vision coverage.
• Life insurance, AD&D, and retirement savings plans.
• Paid time off, sick leave, and paid holidays.
• Training programs and development opportunities.
• Employee discounts, wellness initiatives, and other extra perks.