Analyst II, QA Validation

Job Summary

The Analyst II, QA Validation supports the Validation team by contributing positively and accurately to the completion of all tasks within the related job. Follows standard operating procedures and contributes to the continuous improvement and regulatory compliance within the unit. Makes every effort to complete annual goals established by the department.

Responsibilities

• Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc
• Write summary reports, following good documentation practices
• Use temperature monitoring devices such as the Kaye Validator and/or Ebro dataloggers to perform mapping studies
• Write/update SOPs
• Analyze statistical data to verify acceptable criteria
• Develop testing strategies and rationale for equipment/systems
• Provide technical support/troubleshooting ...