Experience

Clinical ink

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Lead Quality Assurance Analyst

  • Oct 2019 - Present

  • Oversee and assign platform testing tasks to testers • Serve as lead quality contact for the product: o Work with the Development team and Solutions Management team to develop testing strategies and scenarios to effectively qualify Clinical Ink’s legacy platform(s) o Liaise with appropriate project team members for follow-up, resolution, and closeout of qualification and validation activities. • Manage the creation and approval of validation deliverables according to SOPs and Guidelines including, but not limited to: o Validation Plans o Validation Summary Reports o Test Cases • Coordinate and manage test plan execution by: o Managing test case execution o Executing test cases o Documenting defects and tracking through to resolution • Ensure all validation activities and deliverables comply with internal controls and FDA regulations. Show less