Role OverviewThe Senior Quality Assurance Engineer develops and maintains quality metrics to support operations at Vivex Biologics, Inc. They serve as a mentor to Quality Engineer Specialists and Quality Engineers I/II, and work with all departments to ensure compliance and the successful completion of projects.
What You Will Do
The Senior Quality Assurance Engineer will independently lead tasks or projects, conduct root cause investigations, and initiate CAPA system items. They will also collaborate with cross-functional teams, conduct data analysis, and provide Quality-related guidance.
Why It Might Be a Fit
The ideal candidate will have a Bachelor's degree in engineering or a related field, and at least 5-6 years of experience in a related Engineering or Quality role. They will have strong knowledge of FDA, AATB, and cGTP guidelines, and experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
Requirements
- Bachelor's degree in engineering or a related technical discipline
- At least 5-6 years of experience in related Engineering or Quality role
- Strong knowledge of FDA, AATB, and cGTP guidelines
- Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry
- Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs)
- Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint)
- Effective oral, written, communication, and presentation skills
- Strong analytical and problem-solving skills
- Project management skills preferred
Benefits
- Office environment, laboratory environment, occasional clean room access
- Subjected to human tissue and associated hazards and biohazards
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