Senior Quality Assurance Specialist

KEDPLASMA; Town of Tonawanda (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health & Wellness - Medical, dental, &

Financial Security - Life insurance &

Work-Life Balance - PTO & holidays

Career Growth - Training programs

Extra Perks - Discounts & wellness

Job summary

Kedrion Biopharma Inc. seeks a Sr. Quality Assurance Specialist to support quality and regulatory compliance across lab operations.

You will work with the Laboratory Manager to monitor compliance, review documentation, and help train staff while advancing calibration, qualification, and data integrity initiatives. The role emphasizes audit readiness, deviation investigations, and continuous improvement in a highly regulated plasma environment.

Qualifications

• Bachelor's degree in life sciences or a 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 escalate 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

Regulatory compliance

Documentation

Data analysis

Attention to detail

Communication & collaboration

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Data entry systems

Job description

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.

Job Summary

Are you detail-oriented and passionate about quality and compliance? Join our team as a Sr. Quality Assurance Specialist and help ensure the safety and integrity of life-saving plasma products. In this role, you'll be a key player in upholding regulatory standards and supporting continuous improvement across the center's operations.

As a Sr. Quality Assurance Specialist, you'll work closely with the Laboratory Manager to monitor compliance, review documentation, and support training and audit readiness. Your work will support product quality and enhance the current protocols for the laboratory.

What you'll do

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

Qualifications And Need-to-know

• Bachelor's degree in life sciences or a 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.

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary ranges are determined based on relevant experience, education, and certifications.

Employee Benefits:

• Health & Wellness - Full medical, dental, and vision coverage
• Financial Security - Life insurance, AD&D, and retirement savings plans
• Work-Life Balance - Paid time off, sick leave, and paid holidays
• Career Growth - Training programs and development opportunities
• Extra Perks - Employee discounts, wellness initiatives, and more!

For specific inquiries please reach out to us

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.