Lead, Blood Component & QC Laboratory

Blood Bank of Delmarva, Inc.; Newark (DE); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Full Benefits

Job summary

Blood Bank of Delmarva, Inc. is seeking a Manager for the Component & QC Laboratory at the Christiana Donor Center/Headquarters in Newark, DE. You will oversee the blood component manufacturing and quality control testing labs, ensuring safety, purity and potency per FDA/AABB guidance.

You will lead staff, develop SOPs, manage budgets, and drive corrective actions and CAPAs while maintaining rigorous documentation and regulatory compliance across all lab activities.

Qualifications

• Bachelor's degree in biology, chemistry, MLS or related science.
• Associate Degree in MLT with 6+ years in a moderate/high complexity lab.
• 4+ years of laboratory experience in a regulated environment.
• 2+ years in leadership/people management.

Responsibilities

• Manage operation and staffing of blood component manufacturing and QC testing labs.
• Ensure products meet cGMP, FDA, AABB and other regulatory requirements.
• Train, mentor and develop assigned staff; enforce SOPs and policies.
• Plan and direct processing, production, and QA activities to meet goals.
• Review and maintain documentation for receiving, manufacturing, labeling, and QC.
• Lead deviations investigations, CAPAs, and corrective actions.
• Assist budget development and monitor variances; cost analysis for equipment.
• Coordinate audits and ensure timely responses and documentation.

Skills

Leadership experience

Laboratory experience

Quality control

Education

Bachelor's Degree in Biology/ Chemistry/ Medical Laboratory Science

Associate Degree in Medical Laboratory Technology (MLT) with 6+ years experience

Job description

Blood Bank of Delmarva, Inc. is seeking a Manager for the Component & QC Laboratory at the Christiana Donor Center/Headquarters in Newark, DE. You will oversee the blood component manufacturing and quality control testing labs, ensuring safety, purity and potency per FDA/AABB guidance.

You will lead staff, develop SOPs, manage budgets, and drive corrective actions and CAPAs while maintaining rigorous documentation and regulatory compliance across all lab activities.