Job Description
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.