USA - Quality Lab Associate I- Kronos

Target PR: 25.06 *depending on experience

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