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.
