Job Description -
CSV Engineer
Durham, NC
Typical Responsibilities Include:
• CSV QA support in Durham, NC on site .
• Strong knowledge of Data Integrity/ALCOA,
• QA review and approval of SDLC documents - RS, trace matrices, protocols, change controls.
Required experience:
- Quality experience needed.
Nice to have:
- Lab experience a plus
Responsibilities
• Review all IT CSV project and system deliverables including but not limited to:
o Plans
o Requirements
o Specifications
o Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.)
o Summary Reports
o Change Controls
• Review system operational and administration procedures to ensure they are adequate
• Document any findings of non-compliance
• Assist with strategy regarding remediation activities
• Assist with review of remediation activities
• Developing technical documents utilizing a simple non-technical general description. This requires understanding of highly technical automated equipment. • Running test scripts and making recommendations for design or process modification based on test results.
• Owning validation process (or portion thereof) not only from an engineering standpoint but also from a client and team relationship standpoint.
• Developing and writing technical change controls from a general non-technical description of the change to a product, process, equipment, protocol, packaging, outcome, or location of equipment.
• Documenting the planning and design required to support the changes, approvals, and testing.
• Managing the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories.QA