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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