Microbiology Operations Senior Manager

Description 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.

Requirements 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.