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QC Microbiology Analyst Career Profile

The QC Microbiologist is responsible for providing testing and technical support in the Microbiology QC laboratory
Responsibilities:
  • Collection, processing, and testing samples of components, water, bulk and finished products, in-process materials, scale-up, validation, cleaning validations, international components and products and research and development (R&D) to guarantee that they conform with specifications and standard operating procedures (SOPs)
  • Fully proficient in approximately 90% of the laboratory functions
  • Possess foresight to see a task that needs performing and performs the trained task without the request of management
  • Reviews and/or writes the following documents: SOPs, laboratory investigations, development studies and protocols, cleaning validation protocols, and sampling protocols. Provides technical support and trouble-shooting for microbiological issues internally and externally. Complies with cGMPs and safety training and regulations
  • Maintains an environment of respect and teamwork with all coworkers
  • Assists management as a professional advisor and authoritative figure on issues pertaining to specialized and detailed microbiological duties to support internal and external contacts including but not limited to microorganism identification, antimicrobial effectiveness challenge, microbiological testing method validation, and maintenance of bacterial and fungal cultures
  • Performs more advanced microbial testing projects and investigations under the direction of the QC Micro manager
  • Responsible for initiating, researching and writing technical investigations relating to laboratory testing issues. This includes initiating events, when applicable
  • Assists manufacturing and QA in the completion of investigations requiring Microbiological input
  • Communicates with other departments to coordinate efforts for timely release of all material. Assists management as a professional advisor and authoritative figure on issues pertaining to specialized and detailed microbiological duties to support internal and external contacts including but not limited to microorganism identification, antimicrobial effectiveness challenge, microbiological testing method validation, and maintenance of bacterial and fungal cultures