BioAgilytix
Quality Engineer II
Durham, NCftmidAdded yesterday
About this role
BioAgilytix seeks a Quality Engineer II to oversee computer validations and equipment qualifications in a fast-paced bioanalytical services environment. You'll collaborate across teams to ensure quality standards while supporting the development of life-changing therapeutics.
What you'll do
- Provide QA oversight of computer system validations and equipment qualification processes
- Collaborate with cross-functional teams to maintain quality standards and meet business objectives
- Document and review validation protocols and test results
- Ensure compliance with regulatory requirements and company quality procedures
- Support continuous improvement initiatives in QA processes
- Communicate findings and recommendations to stakeholders
What they're looking for
- Quality assurance and validation expertise
- Computer system validation (CSV) knowledge
- Equipment qualification (OQ/PQ/IQ) experience
- Regulatory compliance (FDA, GxP guidelines)
- Technical documentation and writing
- Cross-functional collaboration
- Problem-solving and attention to detail
- Project management
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BioAgilytix
BioAgilytix provides bioanalytical research infrastructure and services that support pharmaceutical development. The company is hiring IT systems engineers to maintain and optimize the networked systems that enable their research operations.
- Website
- bioagilytix.com
Likely interview questions
- Describe your experience with computer system validations and the validation lifecycle you've followed.
- How do you approach collaborating with teams from different departments to ensure quality standards?