Quality Control Laboratory Manager

The Quality Control Laboratory Manager is responsible for managing and controlling all daily operations in the QC Lab, including staff management, compliance with regulations, and ensuring efficient manufacturing and logistics operations for pathogen reduced platelet blood products.

Responsibilities

• Manage laboratory staff and volunteers including hiring, training, coaching, evaluating, and disciplining to ensure a well-qualified team and operational success
• Serve as a resource for supervisors for complex technical issues
• Ensure all functions are performed following applicable regulatory policies and procedures to meet customer needs
• Ensure compliance with state and federal regulations, regional policies, and procedures; coordinate implementation of new or revised tests, procedures, and equipment with SOPs, CFR, and OSHA regulations
• Ensure laboratory training and annual competency assessments are completed in compliance with established guidelines
• May act as a trainer for department-specific curricula
• Manage and evaluate workflow, distribution routes, and processes to ensure efficient manufacturing processes to meet customer demand and timelines cost-efficiently
• Participate in documenting, investigating, troubleshooting, communicating, and preventing recurrence of department problems, concerns, and complaints
• Lead suspect product department investigations and perform supervisory review of documents
• May be responsible for tracking, trending, and analysis of laboratory data and generation of reports
• Serve as a departmental expert on applicable computer systems; responsible for accuracy of computer and physical blood component inventories

Requirements

• Bachelor's degree in an applied science required
• 5 years of related experience with laboratory experience
• 3 years of supervisory or management experience required or equivalent combination of education and experience
• Good communication skills and the ability to interact with diverse customers is required
• Good computer skills and the ability to use the Microsoft suite (Outlook, Excel, Word, PowerPoint) of products is required
• Must meet state and CLIA requirements
• Knowledge of blood products and supplies and the ability to use a wide variety of lab/medical equipment preferred
• MT (ASCP) certifications or equivalent is a plus

Skills

• Laboratory Services Management
• Quality Control
• Staff Supervision
• Regulatory Compliance
• CLIA Requirements
• Blood Products Knowledge
• Laboratory Equipment Operation
• Microsoft Outlook
• MS Excel
• MS Word
• MS PowerPoint
• Applied Science
• Pathogen Reduced Platelet Manufacturing

Languages

English