Microbiology Operations Senior Manager

Job Purpose: 

Microbiology Operations Senior Manager manages and oversees performance of Microbiology laboratory – Quality Control (QC) testing, sample management, inventory, equipment, and special projects. Oversees the completion of Microbiology portions of projects and processes including E/Ps, change control, process development studies, IQ/OQ/PQs, and others. Works with other departments to ensure timely completion of special projects and manages effective workloads. 

Essential Duties and Responsibilities:

• Manages the writing and review of procedures, methods, and testing. 
• Ensures staff training is complete and remains current.  
• Reviews and approves documents for authorization and approval of required or necessary changes to ensure accuracy and completeness.  
• Assists the Director of Microbiology and/or Quality management with project management in regards to investigations,      planned deviations, and CAPA systems.  
• Ensures the purchase of required testing materials, equipment, and services, as well as scheduling the service and      maintenance required by outside providers is complete as necessary. 
• Oversees or performs the review of initiated reports, product development studies, performance qualifications, and investigations for trending, OOS, NCRs, and other materials, as required.  
• Manages Microbiology approvals in TrackWise for documents, batch records, and material and equipment/process      changes.  
• Manages all personnel responsible for document review and equipment/inventory operations to ensure completion of      projects.  
• Oversees the Microbiology Operations Manager to ensure complete management of QC lab analysts/Microbiologists,      Microbiology Laboratory Technicians, and Microbiology Lab Operations Supervisor, and Sample Management Clerks. 
• Assists with troubleshooting for challenges within the Microbiology department.  
• Assists in the management of company initiatives, campaigns, and special projects.  
• Communicates microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Director of Microbiology and/or VP of Quality Systems, or designee. 

Supplemental Functions: 

• Performs other duties as assigned.

  Knowledge & Skills: 

• 2 – 5 years of experience with Microsoft Office applications.  
• Experience with USP Guidelines, cGMP, Aseptic Processing, Aseptic Environmental Monitoring Techniques, and      Microbiological quality control testing. 
• Highly organized, with great written and oral communication skills.  
• Specific expertise, skills, and knowledge within Microbiology gained through education and experience.  
• The ability to manage oneself effectively, demonstrate integrity, be productive under pressure, and achieve developmental goals.  
• Possess a strong attention to detail.  
• An ability to manage a multitude of resources and to be accurate and current with data and information.  
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.  
• The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.  
• The ability to set clear targets and use performance measures to assess risk and manage opportunities effectively.  
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.  
• Incumbents are required to wear specified protective equipment as necessary.  

Education/Experience: 

• Bachelor of Science Degree in Biology, Microbiology, or Life Science with 2 – 5 years of pharmaceutical microbiological experience, preferred.  
• 2 – 5 years of supervisory experience and the ability to supervise, train, and discipline employees.     

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
• Hours of work: Monday thru Friday; 8-hour shift, or as needed based on company demand.  

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