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Microbiology Technologist/Quality Control

Location: Guilford, ME

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Microbiological evaluations used for FDA 510(k) submissions: Ensures product meets applicable testing standard for medical device requirements.
  • FDA 510(k) submissions: Creates and/or assembles all applicable documentation required for FDA 510(k) submission.
  • Research and development of new products: Medium formulations, component qualifications, and functionality of overall product.
  • Chemical validations: Ensures chemical(s) is meeting testing requirements.
  • Incoming chemical QC release: Reviews all necessary documents prior to releasing chemical to production area. All reviewed documents are kept on file.
  • Record keeping: FDA 510(k) submissions, R + D data, SOP, production forms, Certificate of Analysis, etc.
  • Equipment validations: New equipment needs to be qualified for use prior to being used in production.
  • Equipment calibrations: Yearly calibration certification on equipment used for production.
  • Data analysis: Bacterial recovery, product shelf-life results, and accelerated shelf-life.
  • Standard Operating Procedure development: New products will require new procedures to be kept on file in laboratory manual. To be used for training purposes for production personnel.
  • Production process development: Using SOP’s written, develop overall process of product manufacture.
  • Quality Control product inspections: Raw material, in-process material, and finished good inspections.
  • Quality Control finished good release: Proper testing is performed and documented according to applicable finished good. All testing is verified to meet documented specifications prior to release.
  • MSDS Manuals: Maintains and updates MSDS for all chemicals received.
  • Technical Reporting: Evaluates data and writes reports. SOP Review: Recommends modifications of existing quality or production procedures to achieve optimum quality within limits of equipment capability.

Employment Application Process

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