Summary: Responsible for performing microbiological testing and release of incoming materials and finished products.
Duties and Responsibilities:
· Performs microbial testing of raw materials and finished products, and updates lab reports
· Develops, modifies, and maintains appropriate SOPs and test methods for the Microbiology Laboratory
· Utilize, maintains, and troubleshoots microbiological instrumentation such as microscope, autoclave, incubators, refrigerators, freezers, biological safety cabinet, and microbiological incubation system
· Maintains all equipment in the Microbiology Laboratory including scheduled maintenance, calibration, daily checks, etc.
· Performs and document laboratory investigations as necessary
· Performs weekly microbial testing of the DI water system
· Prepares broth for MLT analysis and perform associated testing including Growth Promotion Test
· Maintains cleanliness of the Microbiology Laboratory
· Schedules pick up of hazardous waste as needed
· Assists in validation/verification efforts
· Assists in the preparation for audits/inspections
· Performs environmental monitoring of the warehouse, manufacturing and retention areas
· Manages and maintains the chart recorders
· Manages product retains program for raw materials and finished products
· Performs other related duties as assigned by management
· Maintain inventory stock of media
Work Experience/Qualifications:
· Minimum of 1 years of microbiology lab experience in a cGMP regulated environment
· Working knowledge of aseptic technique and microbiology principles
· Experience with media preparation, growth promotion, Microbial Limits Testing, Antimicrobial Effectiveness Testing and water testing
· Good interpersonal skills
· Ability to work independently and in a team environment
· Ability to follow instructions
· Good attendance and punctuality
· Ability to work well under pressure
· Ability to read, write, and speak English
· Flexibility to changing priorities, work schedule, and the needs of the business
· General proficiency in using Microsoft Word, Excel and Outlook
· Good organizational skills, attention to detail and ability to work effectively in a fast-paced environment
Education Requirements:
· Must have Bachelor’s degree in science or related discipline. Degree in Microbiology preferred.