Supervisor, Microbiology Laboratory

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Summary of Objective:

The primary function is to perform microbiological testing of environmental samples, pharmaceutical starting materials, components, and finished products to client-supplied and Pharmacopoeia methodology, such as USP by regulatory standards with a high level of accuracy and minimal personal error. The ability to successfully interpret and execute technically challenging methodology. Calibration, maintenance, and troubleshooting of equipment. Perform method development, validation, and method transfers including authoring protocols and final reports.  Training of analysts in techniques for which competency has been demonstrated.  Authoring on-time investigations, OOS investigations, and determination of root causes, including working with internal and external customers to resolve issues. Development and implementation of corrective and preventative actions. Review and approval of technical data. Introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation. Write, review, and revise work practices and test methods.   Project management. Generation of quotations for projects around technical expertise. Assist/lead customer audits. Maintain metrics concerning the area of responsibility. Drive on-time completion of testing and data correction activities of all personnel performing testing in area of responsibility Allocation of testing to subordinates including collaboration with other department supervisors to ensure on-time testing for other services. This role has supervisory responsibilities.             

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned.

• Manages a team of Microbiologists who are responsible for overall Microbiology Stability, Release and Environmental Monitoring Testing. This includes oversight of 1st shift and 2nd shift.

• Knowledge of USP/EP general chapters and ICH guidelines. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Implements best practices in the Laboratory to maximize operational efficiency. Creates an environment to support a high awareness of housekeeping and safety, security. Maintains focus of zero laboratory safety incidents.

• Prioritizes resources in the department to ensure adequate resources are available for both personnel and equipment to meet customer requirements to deliver on time test results with optimum customer services. Ensures that staff are properly trained to perform their assigned duties.

• Demonstrates good leadership through effective planning, leading by example, delegating and empowering subordinates appropriately. Manages subordinate performance daily, acting quickly and decisively when required to resolve issues.

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring and employee counseling. Reviews and approves time records, requests for leave and overtime.

• Creates an environment which supports and encourages continuous improvement to eliminate waste, improve productivity and reduce costs where possible.

• Ensure that all Company procedures and disciplines are complied with so that all analysis is performed in accordance with cGMP, customer and applicable regulatory standards.

• This position will require the individual to be on an on-call rotation schedule for off shifts, weekends and holidays in case of emergencies in the stability chambers. Other overtime/weekend work may be required.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Director.

• General knowledge and skills of a wide variety of Analytical Tests for Stability and Release purposes which include (but are not limited to): Temperature Monitoring of various Laboratory equipment, sa