Alltech Consulting Services
Location: Winchester,KY, USA
Date: 2024-12-21T19:06:13Z
Job Description:
Job Description: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 SciencesExperience:* 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
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