Manager, Component & QC Laboratory

Manager, Component & QC Laboratory

Blood Bank of Delmarva

Christiana Donor Center/Headquarters - Newark, DE

***Full Benefits***

The Manager, Component & QC Laboratory position is responsible for managing the operation and staffing of the blood component manufacturing and quality control testing laboratories; ensuring that all products meet cGMP, the safety, purity and potency requirements of the FDA, AABB, and other regulatory agencies.

• Manages, trains, mentors, and develop assigned staff.

• Ensures adherence to SOPs, regulations, guidelines, practices and policies.

• Creating and revising SOPs and other controlled documents.

• Plans and directs the processing and production functions of the laboratory in order to meet goals.

• Ensure appropriate staff scheduling to meet business needs.

• Reviews and maintains documentation associated with receiving, manufacturing, and labeling of blood components.

• Reviews and maintains documentation associated with quality control of blood components.

• Troubleshoots and resolves technical problems and investigates and corrects errors.

• Assist in preparing, developing and monitoring annual budget for each cost center and analyzes and explains any variances.

• Perform cost analysis on equipment purchases, system enhancements, reagents, rental/leasing agreements.

• Manage deviations by investigating, ensuring appropriate corrective and preventive actions are complete, and documenting findings and actions.

• Write and manage validation, verification, and qualification protocols.

• Assist in coordinating department response to audit findings and other CAPAs.

• Assist in the development of new products, in accordance with FDA regulations.

• Ensure that quality control is performed and acceptable. Resolve any problems associated with quality control.

• Ensure that equipment maintenance is performed according to a pre-determined schedule.

• Assist with new computer software, equipment or test method validation, as required.

• Prepare various reports and track and trend departmental data points for assessing efficiencies and workflow.

• Participate and/or lead organizational committees and projects.

• Make recommendations to improve business unit practices and processes.

• Collaborate and communicate with others in the organization and enterprise.

• Attend training and remain current on industry information.

• Any related duties as assigned.

Education:

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

          OR

• Associate Degree as Medical Laboratory Technician (MLT) with a minimum of 6 years of post-graduate experience in a moderate to high complexity laboratory.

Experience:

• 4+ years of experience in a Laboratory or other regulated environment.

• 2+ years of Leadership experience.

• Any combination of education, training, and experience equivalent to the requirements above that have supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

Preferred Qualifications:

• Education: Bachelor's Degree in Medical Laboratory Science with National Certification.

   

• Related Experience: Blood Center Laboratory experience.