Microbiologist - Ampcus Incorporated
Winchester, KY 40391
About the Job
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.
Job Title: Winchester, KY
Location(s): Microbiologist
Specific Duties, Activities, and Responsibilities:
Job Title: Winchester, KY
Location(s): Microbiologist
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 Sciences
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.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Source : Ampcus Incorporated