Manager, Component & QC Laboratory
About The Position
The Manager, Component & QC Laboratory manages the operation and staffing of the blood component manufacturing and quality control testing laboratories. The role ensures products meet current good manufacturing practices (cGMP) and the safety, purity, and potency requirements of the FDA, AABB, and other regulatory agencies. The manager oversees staff development and training, compliance with procedures and regulations, laboratory production and processing, quality control, documentation, equipment maintenance, and laboratory performance. The role also contributes to budgeting, audits and corrective actions, validation activities, product development, process improvement, and organizational projects.
Requirements
- Bachelor’s degree in Biology, Chemistry, Medical Laboratory Science, or another related science; alternatively, an Associate degree as a Medical Laboratory Technician (MLT) with 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.
- Equivalent combinations of education, training, and experience may qualify if they provide 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.
- 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, and ensure staff schedules meet business needs.
- Review and maintain documentation related to receiving, manufacturing, labeling, and quality control of blood components.
- Troubleshoot and resolve technical problems; investigate and correct errors.
- Assist with preparing, developing, and monitoring annual budgets for cost centers, and analyze and explain variances.
- Perform cost analyses 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 departmental responses to audit findings and other corrective and preventive actions (CAPAs).
- Assist in developing new products in accordance with FDA regulations.
- Ensure quality control is performed and acceptable, and resolve associated 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 across the organization and enterprise.
- Attend training and remain current on industry information.
- Perform other related duties as assigned.
Benefits
- Full benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
