Quality Assurance Specialist — Impact Plasma Safety & Growth

KEDPLASMA; Indianapolis (IN); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health & Wellness – Full medical, oral

Financial Security – Life insurance,AD

Work-Life Balance – PTO, sick leave, &

Career Growth – Training programs

Extra Perks – Employee discounts

Job summary

KEDPLASMA, a Kedrion Biopharma Inc. subsidiary, is seeking a detail-oriented Quality Assurance Specialist to uphold regulatory standards and support continuous improvement across the center’s operations.

You will monitor compliance, review documentation, and assist in training and audit readiness to ensure donor safety and product quality. Collaboration with QA Managers and leadership is essential.

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.

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.

Skills

Data analysis

Organization

Documentation

Communication

Microsoft Office

Education

Bachelor’s degree in life sciences

Tools

FDA/cGMP familiarity

Data entry systems

Job description

KEDPLASMA, a Kedrion Biopharma Inc. subsidiary, is seeking a detail-oriented Quality Assurance Specialist to uphold regulatory standards and support continuous improvement across the center’s operations.

You will monitor compliance, review documentation, and assist in training and audit readiness to ensure donor safety and product quality. Collaboration with QA Managers and leadership is essential.