What are the responsibilities and job description for the Associate Product Validation Specialist position at BioFire Diagnostics, LLC?
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Description
The Associate Product Validation Specialist prepares equipment configurations and instrument interfaces, executes quality control testing and validation test cases from the user’s workflow perspective and meticulously documents validation test results. They may be involved in the planning of validation testing, developing test protocols, and identifying and investigating product performance issues.
Principal Contributions / Accountabilities & Associated Activities :
- Prepares equipment configurations and interfaces
- Executes product validation test runs and produces object evidence to support testing
- Reports equipment, procedures, and product testing results
- Identifies testing problems and product issues and reports them to Validation project leads
- Executes quality control testing, documents results and generates reports
- Participates in the analysis of testing issues and product anomalies
- Ensures products meet company requirements
- Writes concise problem statements which describe the issue, resolution, and impact to validation
- Provides input into the validation strategy and testing plans along with other members of the validation team
- Seeks information about the company’s products and their uses
- Prepares for the defense of validations for design reviews, internal audits and assists with preparation for external audits
Experience, Skills & Qualifications :