Key Responsibilities:
Quals:
We are seeking an experienced Quality Operations Engineer contractor to support our GMP biotechnology operations. In this role, you will serve as a hands-on quality partner to Subject Matter Experts (SMEs) across manufacturing, laboratory, and technical functions. Your primary focus will be facilitating the timely and compliant completion of quality records including change controls, deviations, laboratory investigations, and controlled document revisions within our electronic Quality Management System (eQMS). This role will assist with the continued quality oversight of GMP production and testing of clinical trial materials at contract development and manufacturing organizations (CDMOs) and contract testing labs (CTLs). In addition, responsible for review of Regulatory submissions and source data verification. The individual will be a collaborative, quality professional with biotech GMP compliance experience, with exceptional communication skills to support a pipeline of gene editing products. This role will be responsible for document review as well as assisting with the maintenance of phase-appropriate quality systems, including GxP compliance, document control, validation, and quality control. This role is based at Verve's Boston headquarters The ideal candidate brings strong working knowledge of GMP regulations, excellent writing and communication skills, and the ability to guide non-quality personnel through complex quality processes efficiently and without unnecessary burden.
EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
Quality Systems Analyst Quality Systems Analyst • Boston, MA, United States
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