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 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