Manages the day to day operation of the microbiology department to insure smooth flow of samples and testing
Provides laboratory operations leadership
Hires, coaches, reviews, manages, and terminates assigned staff
Prioritizes daily operational activities
Ensures all quality control systems are operational and in force in all operations within scope
Oversees the scheduling of microbiology staff to insure production schedules are met
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
Provides method development leadership and oversight
Builds and maintains positive client relationships
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
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
Interface with and represent 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