Job Type
Full-time
Description
Position Summary
The Microbiology Manager works closely with the Director on department strategy and work projects. Fills in as Microbiologist Subject Matter Expert (SME) as needed. Supervises, schedules and executes on microbiological testing, release of product and testing for validation protocols.
Essential Duties & Responsibilities
- Supervises and coordinates microbiological testing, release of product and testing for validation protocols.
- Performs organism identification.
- Performs technical review of batch filling records to ensure quality of aseptic processes.
- Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests.
- May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.
- Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
- Performs other functions as required or assigned
- Complies with all company policies and standards
Requirements
Position Requirements and Qualifications
- BS or MS in a scientific discipline or equivalent and a minimum 5-10 years related experience.
Special Skills:
- Expert knowledge of scientific principles and concepts.
- Other special projects and/or duties may be assigned by Management.
- Trains other Microbiologist on Department methods, process and procedure.
- Works with other departments to accomplish Company goals or projects.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and/or correspondence.
- Ability to speak effectively before groups or employees of organization.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
Supervisory Responsibility, if any: Yes