Microbiologist I

AVEVA DRUG DELIVERY SYSTEMS INC•Tamarac, FL
•Onsite

About The Position

The QC Microbiologist performs microbiological testing of raw materials, intermediate/finished products, and environmental monitoring. He/She maintains a functional and current GMP compliant microbiology laboratory.

Requirements

  • Bachelor's degree (B.S.) in microbiology or equivalent.
  • Knowledge of FDA, cGMPs, and SOPs related to job requirements.
  • Minimum of 0-2 years of laboratory experience.

Responsibilities

  • Perform microbial testing of finished products, raw materials, and components in a timely manner.
  • Perform environmental monitoring of the manufacturing facility.
  • Review current USP and the regulatory guidance to ensure compliance with current microbiological methods and practices.
  • Responsible for daily monitoring and testing of the Purified Water System, and WFI System.
  • Author, and review of microbiology protocols, reports, STP's and SOP's.
  • Responsible for microbiology testing for weekend and holiday schedules, as needed.
  • Performs trend analysis of microbiology test results from products, water system, environmental monitoring, and author reports.
  • Required to participate in audits and/or consultations with other departments, as required.
  • General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, biohazard waste disposal, sample discard, discard of expired media and reagents, instrument calibration/maintenance/daily monitoring, and inventory/ordering.
  • Works as a member of a team to achieve all outcomes.
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
  • All other relevant duties as assigned.
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