Quality Assurance Validation (QAV) Specialist
Job Description
Job Description
Hello,
I hope you’re doing well.
My name is Vyshu, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Quality Assurance Validation (QAV) Specialist based in Boston, MA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com
Job Title: Quality Assurance Validation (QAV) Specialist
Location: Boston, MA
Job Summary:
The QAV Specialist will support commissioning, qualification, and validation activities for facility and equipment systems. This role focuses on document review, compliance oversight, and supporting the build-out of a new biologic’s facility.
Key Responsibilities:
- Review and approve commissioning and validation documentation
- Ensure compliance with validation protocols and regulatory standards
- Manage deviations and support resolution activities
- Support facility and equipment lifecycle programs
- Provide validation support for biologics processes (isolators, bioreactors, biosafety)
- Collaborate with cross-functional teams during facility build-out
Requirements:
- 5+ years of QA/Validation experience in commissioning and qualification
- Strong background in biologics manufacturing environments
- Expertise in validation documentation, compliance, and deviation management
- Experience supporting facilities projects in a quality role
Preferred:
- Knowledge of facility control and equipment lifecycle programs
- Experience with new facility commissioning/qualification
- Familiarity with biosafety and biologics validation processes
Thanks & Regards,
Vyshnavi Thuraka
Recruiter
Intellectt Inc
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999- Ext: 225