Under limited supervision and guidance of the Microbiology management team, the Microbiologist II 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.
Assists in non-conformance investigations including deviations, and OOT/OOS related to product results and environmental monitoring results.
Issues and revises GMP documents such as SOP’s, protocols/reports, testing monographs, data sheets, etc.
Assists in trainings of new employees.
Identifies and implements improvement opportunities in the Microbiology laboratory, including continuous quality improvement.
Other duties as assigned
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.
EDUCATION AND EXPERIENCE:
Bachelor's degree (B.S.) in Microbiology or Biological Sciences from four-year College or university and at least three years related experience and/or training. One year minimum experience in the pharmaceutical industry working in a GMP environment is preferred; or Master’s (M.S.) degree and one years’ Pharmaceutical 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.
Must be detailed oriented, have a team work attitude with strong interpersonal, organizational, and communication skills.
Will interact with all functional departments within the company as well as contract services.