QA Specialist - Plasma Compliance & Continuous Improvement

Kedrion Biopharma GmbH; Indianapolis (IN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to uphold regulatory standards and support continuous improvement across our plasma center operations.

You will work with the QA Manager and leadership to monitor compliance, review documentation, and assist in training and audit readiness. The role emphasizes donor safety, product quality, and collaboration in a highly regulated environment with exposure to bloodborne pathogens and cold storage areas.

Qualifications

• Bachelor’s degree in life sciences or 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.

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

Regulatory knowledge

Microsoft Office

Education

Bachelor’s degree in life sciences

Tools

Data entry systems

Job description

Kedrion Biopharma Inc. is seeking a Quality Assurance Specialist to uphold regulatory standards and support continuous improvement across our plasma center operations.

You will work with the QA Manager and leadership to monitor compliance, review documentation, and assist in training and audit readiness. The role emphasizes donor safety, product quality, and collaboration in a highly regulated environment with exposure to bloodborne pathogens and cold storage areas.