Laboratory Manager

Job Summary

Oversee daily laboratory operations, including testing specialty plasma samples, ensuring accuracy, efficiency, and compliance with regulatory standards such as FDA cGMP, CLIA, and OSHA requirements.

• Create, update, and enforce Standard Operating Procedures (SOPs) aligned with the Quality Management System (QMS) to ensure consistent execution of laboratory processes.
• Career Growth
• Coordinate laboratory testing activities including sample processing, test execution, instrument calibration, maintenance, troubleshooting, and quality control/assurance.
• Maintain accurate data entry, donor records, and testing documentation, ensuring proper tracking and compliance with program requirements.
• Manage specialty program inventory and collaborate with Supply Chain, Quality, and operational teams to ensure appropriate stock levels and customer fulfillment.
• Implement and validate new testing methods, instruments, and procedures to meet evolving customer and regulatory requirements.
• Schedule and maintain laboratory equipment, including preventative maintenance, calibration, and validation documentation.
• Support internal and external audits by providing required documentation and driving corrective actions where needed.
• Communicate effectively with vendors, technical support teams, and customer representatives to resolve issues and maintain service standards.
• Oversee licensing requirements and support renewal processes to maintain operational compliance.
• Lead, develop, and manage laboratory staff, including hiring, training, coaching, performance management, and workload distribution.
• Foster a positive, collaborative, and performance-driven work environment that supports employee engagement and retention.

Qualifications and need-to-know

• Bachelor’s degree in Life Sciences or a related field required.
• ASCP certification or equivalent national certification required.
• Licensed Clinical Laboratory Supervisor across relevant specialties preferred.
• 5–10 years of experience in a hospital laboratory, plasma, or blood collection environment preferred.
• Knowledge of laboratory testing protocols and viral marker testing preferred.
• Strong understanding of regulatory requirements including FDA cGMP, CLIA, and OSHA standards.
• Demonstrated experience managing laboratory operations, including quality control, equipment maintenance, and testing procedures.
• Proven leadership experience with the ability to manage, coach, and develop team members.
• Experience with laboratory data management and documentation processes.
• Ability to implement new procedures, validate methods, and adapt to evolving operational requirements.