Abacus Service Corporation
Location: Winchester,KY, USA
Date: 2024-12-10T19:59:09Z
Job Description:
Description/Comment: - ONSITE - SHIFT - MON-FRI 7AM-3:30PM - DURATION - 3 MONTHS. 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 Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 110 1100 Enterprise Drive 13-4268760 Winchester KY 40391 United States Education: dditional Job Details:
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