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Lead QAV Specialist at ElevateBio - ApplyBlast

Lead QAV Specialist

ElevateBio

28 days ago

3.5 on Glassdoor

Waltham, Massachusetts, United States

Onsite

Full Time

Senior

0 applicants

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About this role

ElevateBio is seeking a Lead QAV Specialist to provide quality assurance oversight for commissioning, qualification, and validation activities at the BaseCamp Waltham facility. This role ensures cGMP compliance across validation master plans, facility and equipment qualification, and supports risk assessments, change controls, and CAPAs. The position involves managing a team of QAV personnel and serving as a quality subject matter expert for engineering and relocation programs.

Responsibilities

Lead QA oversight for commissioning, qualification, and validation activities
Manage cGMP compliance for facility and equipment qualification programs
Support risk assessments, change controls, deviations, and CAPAs

Skills

About ElevateBio

elevate.bio

Headquarters

Waltham, Massachusetts, United States

Company Size

201-500 employees

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ElevateBio is a life sciences company that accelerates the creation of cell and gene therapies by combining integrated technology platforms with development and manufacturing capabilities. It partners with biotech and research teams to provide end-to-end support — from technology development and process optimization to clinical- and commercial-scale manufacturing — aimed at speeding programs to clinic and market. Customers choose ElevateBio for its integrated approach, manufacturing footprint, and expertise in translating genetic medicine programs at scale.