Plasma Quality Assurance & Compliance Specialist

Kedrion; Spring Hill (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc.’s Kedplasma center in Florida is hiring a Quality Assurance Specialist to uphold regulatory standards and drive continuous improvement. You will review documentation, monitor compliance, and support training and audit readiness to protect donor safety and product quality.

The role partners with QA leadership and center staff to ensure accurate data, proper storage, and timely corrective actions. A life sciences background with GMP familiarity is preferred.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 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.

Responsibilities

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

Data analysis

Documentation

Communication

Collaboration

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Kedrion Biopharma Inc.’s Kedplasma center in Florida is hiring a Quality Assurance Specialist to uphold regulatory standards and drive continuous improvement. You will review documentation, monitor compliance, and support training and audit readiness to protect donor safety and product quality.

The role partners with QA leadership and center staff to ensure accurate data, proper storage, and timely corrective actions. A life sciences background with GMP familiarity is preferred.