Manages the day to day operation of the microbiology department to ensure smooth flow of samples and testing. Provides laboratory operations leadership, hires, coaches, reviews, manages, and terminates assigned staff. Prioritizes daily operational activities and ensures all quality control systems are operational and in force in all operations within scope. Oversees the scheduling of microbiology staff to ensure production schedules are met and maintains staffing to achieve workload goals by adjusting personnel to meet peak demands. Ensures Key Performance Indicators (KPI's) are in place, relevant, and continually evaluated. Prepares for and facilitates periodic customer or regulatory audits of all laboratories within scope. Maintains current knowledge of industry standards and regulatory environment. Reviews and approves SOPs. Actively participates in strategic planning and provides method development leadership and oversight. Builds and maintains positive client relationships and ensures client satisfaction. Counsels microbiology staff with regard to problems encountered in daily operations. Oversees the checking and transfer of microbiology data as necessary and takes steps to correct possibly inaccurate data prior to continued processing or release. Oversees the orientation of new microbiology staff to their responsibilities and the function of the microbiology department. Conducts timely investigations in coordination with Quality Assurance related to site quality events, including, but not limited to customer complaints, inquiries, non-conformances, corrective actions, and audit findings. Identifies process improvements to better meet client expectations and company objectives. Recommends new equipment for the microbiology department. Compiles statistics and oversees the monitoring of inventory/ordering by establishing and maintaining par levels and re-stocking points for microbiology supplies and reagents. Serves as a liaison for the department to outside vendors. Assists in capital budgeting and execution. Understands costs of testing and how to calculate them. Initiates advances in methodology and/or technology use. Interfaces with and represents laboratory operations to local, state, and federal regulators as required from time to time. Performs duties in compliance with all applicable regulatory and accrediting agencies and cGMP expectations, including but not limited to: Facility and equipment maintenance, validation review and approval, training (internal, continuing education, proficiency testing, annual GMP, etc.). Performs annual reviews and creates and maintains job plans. Executes human resources management functions as required for laboratory staff within scope.
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Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Education Level
Bachelor's degree