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Job Title: Validations Specialist (Job # 6455) | Apply Now
Job Description: Responsibilities:
Prepare executable Quality Test Protocol documentation to test internal machine functionality and assist the customer in their internal Validation of the purchased machine(s). Executes part or all of Quality Test Protocol Documentation. Supports the Quality department by writing and maintaining material for work methods, procedures and related material for the installation, operation, maintenance and training related to machinery.
1. Create Quality Test Protocol Documentation with the primary focus on HMI push button presence and functionality, Fault and Status message description, machine response, simulations, and corrective action, and verification of machine components to supporting documentation (functional spec, schematic, program codes, etc.).
2. Produce project Quality Test Protocol Documentation and assist Controls Designer with project testing of machine functionality.
3. Backup Quality Support – may assist assembly team in the execution of part or all of Quality Test Protocol Documentation as required.
4. Assist internal customers in conducting root cause analysis of any discrepancies found during the execution of the Quality Test Protocol Documentation.
5. Incorporate customer feedback into continuous improvement activities for the process of creating Quality Test Protocol Documentation.
1. Verify that functional specifications and deliverables are met prior to shipment
2. Understand GAMP5 requirements
3. Standards-Maintain Quality Test Protocol Documentation and appendix templates with specific direction
4. Conduct verification of completion of Quality Test Protocol Documentation as well as any supporting documentation updates made as a direct impact of executing the test protocol.
1. Associates Degree in related field
2. 2+ years related work experience preferred
3. Demonstrated Technical writing experience
4. Quality background and knowledge of GAMP5 requirements
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