Associate I, Quality Lab

4 weeks ago

marion, United States Planet Pharma Full time

Position Summary:

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

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