Microbiologist I

Avion PharmaceuticalsFort Worth, TX
Onsite

About The Position

A Microbiologist 1 is responsible for the testing of all raw materials, finished products, stability program batches, and research/validation batches. Additional tasks include testing related to critical systems in the plant such as the purified water system and controlled manufacturing rooms, as well as equipment. Many task-related responsibilities are also required and listed below.

Requirements

  • Bachelor’s degree in microbiology, biology, or related scientific field or equivalent experience
  • Six (6) months to three (3) years of experience in a pharmaceutical microbiology laboratory
  • Knowledge of cGMP/GLP/GDP, USP / EU regulatory requirements
  • Experience performing microbiological testing / environmental monitoring using aseptic techniques
  • Excellent interpersonal communication and organizational skills
  • Qualified to work with controlled substances
  • Knowledge and experience performing serial dilutions
  • Experience Handling Biohazardous materials
  • Authorized to work in the United States
  • DEA clearance (After Hire)

Responsibilities

  • Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations
  • Perform microbiological testing related to the following microbiological test methods: Microbial Enumeration and Specified Microorganism (MET / SMT) testing per USP <61>/<62>
  • Antimicrobial Effectiveness Testing (AET) per USP <51>
  • Preservative Effectiveness Testing (PET) per USP <51>
  • Purified/Source Water testing per USP <1231>
  • Environmental Monitoring (EM)
  • Water Activity Determination per USP <1112>
  • Cleaning validation / verification microbiological recovery testing
  • Microbiological growth promotion and sterility verification testing
  • Adhere to controlled substance requirements
  • Receive, and release media, buffers, and microorganism cultures
  • Update and review microbiological trending
  • Review / record daily temperature readings
  • Sanitize the laboratory incubators and refrigerators
  • Review media, material, and supply inventories
  • Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work
  • Clean and sanitize the microbiology laboratory rooms surfaces and equipment
  • Perform any additional routine or non-routine microbiological tasks not listed in this document
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