Microbiology Manager

Under the general supervision of the Associate Director of Microbiology, the Microbiology Manager ensures staff is trained, troubleshoots microbiological test excursions, develops and implements new microbiological procedures and equipment This individual also ensures testing is conducted in accordance with SOPs and Methods, and ensures department SOP's and Methods meet Company and FDA standards.

• Schedules and supervises microbiological activities to ensure testing is performed and reported in a timely manner.
• Coordinates EM monitoring activities and ensures the trend reports are completed as per the schedules.
• Conducts or delegates the Purchase Order program for the department while ensuring that the departmental budget is met.
• Supervising training adequacy, adherence to SOPs and methods based on company and regulation standards.
• Coordinates the development and qualification of non-routine microbiological test methods.
• Assists in the coordination of microbiological testing support for Validation, Regulatory Affairs, Quality Control, and Quality Assurance.
• Initiates and assists in performing investigations following deviations and non-conformances in Trackwise software.
• Initiates Change Controls as required by Akorn procedures.
• Ensure lab equipment is adequately maintained and calibrated.
• Coordinates work with Engineering, Metrology, Validation, and other departments as necessary to qualify new equipment.
• Continuously improves SOPs and processes.
• Provide support during internal and external audits.
• Evaluates and approves employees' timecards and PTO requests.
• Performs employees' performance appraisal in a timely manner.
• Assists in the interview process of new personnel (Microbiologists and Technicians).
• Conduct regular lab meetings and ensure proper communication of business activity to the team.
• Maintain a safe and professional environment in the Microbiology Lab.