Role: Microbiologist
Duration: 03 Months
Location: Winchester, KY
Shift - Mon-Fri 7AM-3:30PM
Specific Duties, Activities, and Responsibilities:
- Compile and interpret results of microbiology and environmental monitoring tests and results.
- Maintain, clean, and sterilize laboratory instruments and equipment.
- Conduct chemical and physical laboratory tests to assist scientists in making qualitative and quantitative analyses.
- Robust understanding of the regulatory requirements.
- Able to compose robust investigations for microbiology, environmental monitoring and support of manufacturing investigations.
- Write technical reports or prepare graphs and charts to document experimental results.
- Perform water sampling, including DI water, WFI and steam
- Perform sterility testing of finished produce
- Perform bioburden testing of raw materials, WFI and bulk product
- Perform bacterial endotoxin testing of WFI and bulk product
- Subculture and characterize microbial isolates using the Gram stain and differential tests such as the catalase and oxidase reaction, prepare shipments of subcultures for identification
- Perform growth promotion testing of liquid and plated media, including media fills
- Perform environmental monitoring of laboratory areas
- Perform bacteriostasis/fungi stasis testing to validate test methods
- Process and incubate exposed biological indicators
- Incubate and read media fills
- Identifies micro-organisms by microscopic examination of physiological, morphological, and cultural characteristics.
- Receive and prepare samples and equipment for testing, including but not limited to finished product and bioburden
- Incubate and examine tests, including but not limited to bioburden, sterility, Bis and media fill units
- Enumerate bacteria; prepare shipments for outside laboratories
- Understand the science behind the above listed testing requirements, be able to clearly communicate testing requirements and expectations.
- Understand environmental monitoring, the different testing requirements and the interpretation of the results.
- Detail oriented to perform peer review of results, investigations and protocols.
- Operate and maintain laboratory equipment, including but not limited to incubators, autoclaves, ovens, vacuum pumps; assist with qualifications and validations
- Maintain current training status on equipment and procedures
- Perform documentation per cGMP; prepare and assist with preliminary and full investigations
- Support R&D and Technical Services activities
- Assist with FDA and customer audits
- Assist with and conduct studies as requested by the Lab Supervisor
- Maintain effectiveness of the Quality System components relevant to this position.
Position Requirements:
- B.S. in Microbiology or Biological Science
Experience:
- 0-4 years’ experience
- Previous pharmaceutical experience desired.
Knowledge/Skills Requirements:
- Demonstrated intermediate mathematical ability.
- High level of attention to detail.
- Excellent documentation skills.
- Strong Mechanical aptitude.
- Strong communication skills both written and oral.
- A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.
- Strong problem solving and analytical skills.
- Must possess appropriate communication skills allowing direct interaction with outside suppliers, STW internal Managers and Sr. Management.
- Works well in a team environment.
- Possess and demonstrate excellent verbal, written and interpersonal communications skills.
- Excellent problem solving and analytical skills.
- Well organized and detail and multi-task oriented.
- Works well under pressure and able to prioritize workloads.
- Must be able