Location: Edison, NJ
Date Posted: 04-01-2018
Under limited supervision and guidance of the Microbiology management team, the Microbiologist III is responsible for the following duties:
Include the following. Other duties may be assigned.
  • Performs routine microbiological testing of products, raw materials, components and controlled environments according to site Standard Operating Procedures and compendial methods.
  • Knowledge of or experience in the following:
  • Method Suitability and routine:
  • Sterility Testing by Membrane Filtration and Direct Inoculation
  • Microbial Limit Testing (formulated product, raw materials and packaging components)
  • Antimicrobial Effectiveness Testing
  • Antibiotic Microbial Assays for Potency Determination
  • Bacterial Endotoxin Testing
  • Environmental Monitoring of controlled, classified areas including the use of Contact Plates, Settling Plates, and Air Samplers.
  • Total Heterotrophic Plate Count of potable and Process Water
  • Preparation, Sterilization, Incubation, and Growth Promotion of culture media
  • Disinfectants and lethality studies
  • Population Determination and Testing of Biological Indicators; operation of autoclaves
  • Identification of microbial organisms
  • Documents routine procedures following laboratory and company guidelines.
  • Performs non-conformance investigations including deviations, and OOT/OOS related to product results and environmental monitoring results.
  • Generates, executes, and completes CAPAs.
  • Issues and revises GMP documents such as SOP’s, protocols/reports, testing monographs, data sheets, etc.
  • Creates and executes equipment qualification protocols; ensures laboratory equipment remains in a calibrated and properly functioning state.
  • Reviews and approves laboratory generated data in data reviewer absence
  • Reviews and approves product specification for release in management absence 
    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    Bachelor's degree (B.S.) from four-year college or university with Major in Biology/Microbiology and 6 years related experience and/or training in the pharmaceutical industry or life sciences field; or MS degree and 3 years’ experience.
  • Ability to meet attendance standards.  All full-time employees are required to work a minimum 40-hr week.  At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
  • Knowledge of GMP specializing in sterile dosage forms, USP testing requirements for sterile products and Microbiological procedures, 21 CFR parts 210/211, and other FDA regulations /guidelines is preferred.
  • Computer proficiency in Microsoft Word, Excel, Access and Outlook and the ability to use enterprise software; preferably TrackWise, LIMS, iStability, Vitek, or related systems.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
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