Responsible for reading plates for EM, Bioburden, and special project testing and recording test results. Performs additional microbiological testing as required.
Job Responsibilities:
Operate lab equipment such as laminar flow hoods, autoclave, incubators, and other equipment
Read plates and enter test results and other data into LIMS
Initiate paperwork for microbial out of limit investigations and provide needed information to Investigators
Perform monthly safety audits
Sustain a clean and safe work environment utilizing 6S principles
Perform growth promotion testing and media sterility verification; release media in BLAS and LIMS
Approve paperwork including Microbial Identification forms, media production, growth tests, and incubator logs
Assist in assimilating the monthly Microbial Identification report
Prepare media used for microbiological testing such as TSA and TSB
Perform Thermal Death Time testing
Responsible for general housekeeping of Laboratory
Knowledge, Skills, and Abilities:
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Familiarity with quality based computer systems such as LIMS
Attention to detail and ability to prioritize multiple tasks in a timely manner
Must have a basic understanding of laboratory instrumentation and equipment such as laminar flow hoods, autoclaves, incubators
Good documentation skills and knowledge of GDPs (Good Documentation Practices)
Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
Must be able to communicate effectively with supervisors and peers
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
Must be experienced in executing general microbiology procedures
Must be able to lift 50 lbs
Required Education and Experience:
B.S. degree in Microbiology, Biology, or related science
0-2 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry preferred