Blood Component & QC Lab Operations Manager

Blood Bank of Delmarva (BBD); Newark (DE); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Full Benefits

Job summary

Blood Bank of Delmarva is seeking a Manager, Component & QC Laboratory in Newark, DE to oversee the blood component manufacturing and QA testing labs. You will lead staff, ensure SOP compliance, and manage documentation, budgets, audits, and process improvements in a high‑regulation setting.

You will drive quality control, validate methods, coordinate CAPAs, and collaborate across departments to deliver safe, accurate blood products. Prior experience in regulated labs is essential.

Qualifications

• Bachelor’s degree in biology, chemistry, medical laboratory science or related sciences.
• Associate degree with 6+ years experience in a moderate to high complexity lab.

Responsibilities

• Manages, trains, mentors, and develops assigned staff.
• Ensures adherence to SOPs, regulations, guidelines, practices and policies.
• Creates and revises SOPs and other controlled documents.
• Plans and directs processing and production functions of the lab to meet goals.
• Schedules staff to meet business needs.
• Reviews documentation for receiving, manufacturing, and labeling of blood components.
• Reviews documentation for quality control of blood components.
• Troubleshoots and resolves technical problems; investigates and corrects errors.
• Assists in budgeting and analyzes variances for cost centers.
• Performs cost analysis on equipment purchases, system enhancements, reagents, and leasing agreements.
• Manages deviations; investigates, documents CAPA actions.
• Writes and manages validation, verification, and qualification protocols.
• Coordinates responses to audits and CAPAs.
• Develops new products per FDA regulations.
• Ensures quality control is performed and issues resolved.
• Ensures equipment maintenance per schedule.
• Assists with software, equipment or test-method validation.
• Prepares reports and tracks departmental data for efficiency and workflow.
• Participates in organizational committees and projects.
• Recommends improvements to business unit practices and processes.
• Collaborates and communicates across the organization.
• Attends training and stays current on industry information.
• Performs any related duties as assigned.

Skills

Leadership

Staff development

Compliance

Regulatory knowledge

Budgeting

Education

Bachelor's Degree in Biology, Chemistry, Medical Laboratory Science, or related sciences

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

Job description

Blood Bank of Delmarva is seeking a Manager, Component & QC Laboratory in Newark, DE to oversee the blood component manufacturing and QA testing labs. You will lead staff, ensure SOP compliance, and manage documentation, budgets, audits, and process improvements in a high‑regulation setting.

You will drive quality control, validate methods, coordinate CAPAs, and collaborate across departments to deliver safe, accurate blood products. Prior experience in regulated labs is essential.