Quality Lab Associate

Job Description

Job Summary:

• Responsible for reading plates for EM, Bioburden, and special project testing and recording test results.
• Performs additional microbiological testing as required.

Duties and 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.

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.

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.