Specialist I, Visual Inspection

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is looking for a Visual Inspection (VI) Specialist to lead the Visual Inspection Program at our Waltham BaseCamp facility. This individual will be responsible for managing site visual inspection procedures, executing inspector training and qualification, and supporting investigations and quality event documentation associated with visual inspection of final drug products. The VI Specialist will work cross-functionally with QA, QC, Manufacturing, and MSAT to ensure compliance with applicable standards and regulatory expectations.

Here’s What You’ll Do:

Own and maintain the site Visual Inspection Program, including procedures, work instructions, and standards for drug product inspection

Lead training and qualification activities for visual inspectors; maintain requalification schedules

Support and execute qualification of inspection stations and defect kits

Lead or support investigations and documentation of quality events related to visual inspection, including deviations and discrepancies

Provide guidance to Manufacturing and Quality stakeholders on VI-related best practices and compliance expectations

Analyze inspection and particulate data to identify trends and recommend improvements

Support internal and external audit readiness for all VI-related topics

Collaborate with cross-functional teams during batch disposition to assess VI acceptability and ensure compliant batch release decisions

Support onboarding of new partners and manufacturing processes by developing and implementing visual inspection programs as part of technology transfer activities, ensuring alignment with client specifications and regulatory expectations

Requirements:

Bachelor’s Degree in Life Sciences, Engineering, or a related technical discipline, or equivalent experience

3+ years of experience in a GMP manufacturing, QA, or QC role supporting sterile products or visual inspection

Demonstrated understanding of visual inspection principles, particulate classification, and regulatory requirements, including:

21 CFR Part 211 (e.g., 211.94 and 211.110)

EU Annex 1: Manufacture of Sterile Medicinal Products

USP <790> Visible Particulates in Injections

USP <1790> Visual Inspection of Injections

Experience in cell and gene therapy, aseptic processing, or parenteral product inspection preferred

Strong communication skills and ability to work cross-functionally with technical and quality teams

Familiarity with electronic systems used in GMP environments such as Veeva, TrackWise, or electronic batch records

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:

To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:

We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.