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 product.
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/fungistasis 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.
Other duties as assigned.
Will be working with a team of 10 in a lab environment.
Will conduct chemical and physical laboratory tests to assist scientists in making qualitative and quantitative analyses.
Example - Enumerate Bactria testing, Water Sampling, Bioburden on raw material, bacteriostasis/fungistasis etc.
Must have BA in Life sciences (Preferably microbiology).
New grads with a Life Science degree would be a good fit for this position. (Class room or class lab experience in testing is preferred)
Must have a strong attention to detail.
Must have strong communication both written and verbal. familiar with handling organisms.
Work well as a team. Must have the ability self-manage and be able to identify new tasks and willing to take on additional tasks.
See things that need to be done and do them.
Must have Min of BA in Life sciences - Preferred Microbiology.
Experience Requirements: Open to new grads with Life sciences degrees
Computer: basic to intermediate experience with Word/Excel; ability to navigate basic computer systems.
Equipment: standard lab equipment/environment
Instrument: bacterial isolate culture instrument, inoculating loop, agar plate etc.
Work Environment: Lab environment almost exclusively with occasional in manufacturing suites once trained and certified, fast paced, can be loud at times