Microbiologist

Job Description

Job Summary:

• Execute a variety of laboratory tasks related to microbiological testing of pharmaceutical products, raw materials, and medical devices.
• Perform microbiological testing in a Biosafety Level-2 laboratory under GLP conditions.
• Responsibilities include planning and carrying out studies inside a Biosafety Cabinet, maintaining microbiological cultures, analyzing and recording viable counts of microorganisms (CFU).

Duties and Responsibilities:

• Perform routine and non-routine USP, ASTM, ISO, and CLSI based microbiological testing for anti-infective, antiseptic, or disinfectant efficacy (i.e., time-kill assay, MIC/MBC, sterility testing, microbial limits, bioburden).
• Execute testing following standard operating procedures in a BioSafety Level-2 Laboratory.
• Assist in the qualification and validation of equipment and lab instruments including calibration under established procedures.
• Maintain laboratory notebooks following good documentation practice (GDP) and good laboratory practices (GLP) to support compliance with GLP.
• Work proactively and independently with minimal oversight/supervision to complete projects.
• Upon request from supervisor, coordinate/lead test requests.

Education and Experience:

• Bachelor of Science (BS) Degree in Microbiology/Biological Sciences/Chemistry.
• Minimum of 1+ years of experience in a laboratory setting of microbiology or related industrial experience (pharmaceuticals, medical devices, personal care, or cosmetics) in R&D or QC required.
• Experience performing microbiology testing in a GXP laboratory.
• Experience working with LIMS data management software.
• Experience supporting internal laboratory investigations such as OOS (out of specification), OOT (out of trend), and protocol deviations.

Required Skills:

• Working as part of a team is required.
• Detail-oriented with excellent organizational skills.
• Ability to organize and prioritize work with limited guidance.
• Experience working in a Biosafety Level-2 laboratory, academic or industrial.

Physical Demands:

• Standing or sitting at a laboratory bench for extended periods of time.
• Work for extended periods of time in front of a biological safety cabinet.
• Able to lift 25 lbs.
• Wear PPE appropriate for a BSL-2 laboratory.

Work Environment:

• BSL-2 Laboratory environment using personal protective equipment (PPE).
• May encounter/use biological, chemical, or human body fluid for testing and handle biohazardous waste.