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. Planning and carrying out studies inside a BioSafety Cabinet, maintaining microbiological cultures, analyzing and recording viable counts of microorganisms (CFU).
Job 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).
- Assists in the qualification and validation of equipment and lab instruments, including calibration under established procedures.
- Responsible for maintaining laboratory notebooks following good documentation practice (GDP), good laboratory practices (GLP) and supporting compliance with GLP.
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 industry experience (pharmaceuticals, medical devices, personal care, or cosmetics) in R&D or QC required.Experience working in a BioSafety Level-2 laboratory, academic, or industrialPreferred Skills :
Experience performing microbiology testing in a GXP laboratoryExperience working with LIMS data management softwareExperience supporting internal laboratory investigations such as OOS (out of specification), OOT (out of trend), and protocol deviationsWear PPE appropriate for a BSL-2 laboratory