Microbiologist I
Quality Systems
position title
Microbiologist 1
reports to
Microbiology Manager
implementation date
September 2, 2020
summary / objective
A Microbiologist 1 is responsible for the testing of all raw materials, finished products, stability program batches and research / validation batches. Additional tasks include testing related to critical systems in the plant such as the purified water system and controlled manufacturing rooms and equipment is also required. Many task related responsibilities are also required and listed below.
essential functions
- Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations
- Perform microbiological testing related for the following microbiological test methods:
- Microbial Enumeration and Specified Microorganism (MET / SMT) testing per USP <61>/<62>
- Antimicrobial Effectiveness Testing (AET) per USP <51>
- Preservative Effectiveness Testing (PET) per USP <51>
- Purified/Source Water testing per USP <1231>
- Environmental Monitoring (EM)
- Water Activity Determination per USP <1112>
- Cleaning validation / verification microbiological recovery testing
- Microbiological growth promotion and sterility verification testing
- Adhere to controlled substance requirements
- Receive, and release media, buffers, and microorganism cultures
- Update and review microbiological trending
- Review / record daily temperature readings
- Sanitize the laboratory incubators and refrigerators
- Review media, material, and supply inventories
- Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work
- Clean and sanitize the microbiology laboratory rooms surfaces and equipment
- Perform any additional routine or non-routine microbiological tasks not listed in this document
supervisory responsibility
This position does not have any supervisory responsibilities.
work environment
This job operates in a professional office environment and business casual attire with closed toe shoes with socks is required. This role routinely uses standard office equipment such as computers, phones, photocopiers and fax machines. This role requires Good Hygiene and facial hair must be neat and tight and kept well-trimmed to prevent incidental contamination during testing. Working with Biohazardous materials is also prominent.
physical demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this position, the employee is regularly required to sit and use hands to finger, handle, or feel objects, tools or controls or to document testing. The employee is also occasionally required to stand for long periods of time collecting or processing samples. The employee must regularly lift and move up to 50 pounds. Specific vision abilities required by this position include close vision, color vision, and the ability to adjust focus.
position type/expected hours of work
This is a full-time position. Days and hours of work are Monday through Friday on 1st shift but earlier or later times or weekend work may be required when the production needs exist.
travel
Travel is limited and may be primarily local during the business day but some out-of-area / overnight travel may be expected.
required education and experience
Bachelor’s degree in microbiology, biology, or related scientific field or equivalent experience
preferred education and experience
- Six (6) months to three (3) years of experience in a pharmaceutical microbiology laboratory
- Knowledge of cGMP/GLP/GDP, USP / EU regulatory requirements
- Experience performing microbiological testing / environmental monitoring using aseptic techniques
- Excellent interpersonal communication and organizational skills
- Qualified to work with controlled substances
- Knowledge and experience performing serial dilutions
- Experience Handling Biohazardous materials
