Manager, Component & QC Laboratory

Blood Bank of Delmarva•Newark, DE

6d•Onsite

About The Position

The Manager, Component & QC Laboratory is responsible for managing the operation and staffing of the blood component manufacturing and quality control testing laboratories. The role ensures that products meet cGMP and the safety, purity, and potency requirements of the FDA, AABB, and other regulatory agencies. The manager leads and develops staff, oversees laboratory processing and production, maintains controlled documentation, and ensures that quality control, equipment maintenance, and staffing meet operational and regulatory requirements. The role also supports budgeting, cost analysis, investigations and corrective actions, validations, audits, product development, reporting, and organizational projects. Blood Bank of Delmarva is part of New York Blood Center Enterprises. The organization describes its work as a lifesaving mission and provides blood products and related services to hospitals and healthcare partners. The employer is an Equal Employment Opportunity employer.

Requirements

Bachelor's degree in Biology, Chemistry, Medical Laboratory Science, or another related science; alternatively, an Associate degree as a Medical Laboratory Technician (MLT) and at least 6 years of post-graduate experience in a moderate- to high-complexity laboratory.
At least 4 years of experience in a laboratory or other regulated environment.
At least 2 years of leadership experience.
A combination of education, training, and experience equivalent to the stated requirements may qualify if it provides the knowledge, skills, and experience needed to perform the essential functions.

Nice To Haves

Bachelor's degree in Medical Laboratory Science with national certification.
Blood center laboratory experience.

Responsibilities

Manage the operation and staffing of the blood component manufacturing and quality control testing laboratories, ensuring products meet cGMP and applicable regulatory requirements.
Manage, train, mentor, and develop assigned staff.
Ensure adherence to SOPs, regulations, guidelines, practices, and policies.
Create and revise SOPs and other controlled documents.
Plan and direct laboratory processing and production to meet goals.
Ensure appropriate staff scheduling to meet business needs.
Review and maintain documentation related to receiving, manufacturing, and labeling blood components.
Review and maintain documentation related to quality control of blood components.
Troubleshoot and resolve technical problems, and investigate and correct errors.
Assist in preparing, developing, and monitoring annual budgets for each cost center; analyze and explain variances.
Perform cost analysis for equipment purchases, system enhancements, reagents, and rental or leasing agreements.
Manage deviations by investigating them, ensuring corrective and preventive actions are completed, and documenting findings and actions.
Write and manage validation, verification, and qualification protocols.
Assist in coordinating department responses to audit findings and other CAPAs.
Assist in developing new products in accordance with FDA regulations.
Ensure quality control is performed and acceptable, and resolve related problems.
Ensure equipment maintenance is performed according to a predetermined schedule.
Assist with validation of new computer software, equipment, or test methods as required.
Prepare reports and track and trend departmental data to assess efficiencies and workflow.
Participate in or lead organizational committees and projects.
Recommend improvements to business unit practices and processes.
Collaborate and communicate with others in the organization and enterprise.
Attend training and remain current on industry information.
Perform other related duties as assigned.