Quality Assurance Specialist
KEDPLASMA
Summary
Are you detail-oriented and passionate about quality and compliance? Join our team as a 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.
Job description
Job Summary
Are you detail-oriented and passionate about quality and compliance? Join our team as a 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 Quality Assurance Specialist, you'll work closely with the Quality Assurance Manager and center leadership to monitor compliance, review documentation, and support training and audit readiness. Your work will directly impact donor safety and product quality.
What you'll do
- 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.
Qualifications And Need-to-know
- Bachelor's degree in life sciences or a 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.
Requirements
- Bachelor's degree in life sciences or a related field preferred
- Minimum 1 year of experience in a regulated industry
- Plasma center or biomedical field experience 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
Benefits
- Medical, Dental & Vision
- Life Insurance
- AD&D Insurance
- Retirement Savings Plans
- Paid Time Off
- Sick Leave
- Paid Holidays
- Training Programs
- Development Opportunities
- Employee Discounts
- Wellness Initiatives
Company overview
KEDPLASMA is a leading plasma collection and procurement company operating as a subsidiary of Kedrion Biopharma, an international biopharmaceutical company. Established in 2004, KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-derived medicinal products for treating severe and often rare diseases, disorders, and conditions such as Hemophilia and Immunodeficiencies. The company operates a capillary network of plasma centers with over 70 locations across the United States and 5 centers in the Czech Republic. KEDPLASMA employs more than 900 people and manages specialized plasma donation programs including Anti-D, Tetanus, Anti-smallpox, Anti-hepatitis B, Anthrax, Rabies, Viral Inactivation, CMV, and Anti-varicella zoster programs. The company plays a critical role in the plasma supply chain by collecting source plasma that undergoes rigorous quality control checks before being transformed into life-saving therapies distributed globally by its parent company, Kedrion Biopharma, which produces 37 plasma-derived products distributed in over 100 countries.