Senior QA Specialist: Regulated Plasma Lab & Compliance

KEDPLASMA LLC; Town of Amherst (NY); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health & Wellness – Medical, dental, &

Retirement plans

Paid time off

Training programs

Employee discounts

Job summary

Kedrion Biopharma Inc. is hiring a Senior Quality Assurance Specialist to ensure the safety and integrity of plasma products. You will work with the Laboratory Manager to monitor compliance, review documentation, and support training and audit readiness.

The role focuses on maintaining regulatory standards, supporting continuous improvement, and ensuring data integrity across lab operations. Strong attention to detail and collaboration with cross-functional teams are essential.

Qualifications

• Bachelor’s degree in life sciences or related field preferred.
• Minimum two years’ experience in a laboratory setting 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 plasma products.
• 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.
• Draft protocols for new and existing instruments and processes within the lab.
• Monitor plasma centers for compliance with customer requirements.
• Ensure proper storage and documentation of supplies, reagents, and equipment.
• Perform quality control checks on stored and shipped products, as well as test reagents.
• Perform reviews of completed runs and changes in supply lots.
• 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.
• Promote a culture of continuous improvement and regulatory excellence.

Skills

Data analysis

Regulatory compliance

Documentation

Communication

Collaboration

Quality assurance

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

Kedrion Biopharma Inc. is hiring a Senior Quality Assurance Specialist to ensure the safety and integrity of plasma products. You will work with the Laboratory Manager to monitor compliance, review documentation, and support training and audit readiness.

The role focuses on maintaining regulatory standards, supporting continuous improvement, and ensuring data integrity across lab operations. Strong attention to detail and collaboration with cross-functional teams are essential.