28 applicants

Company

Original Job Post

ElevateBio · 2 days ago

Associate I, Quality Assurance

Waltham, MA

Contract

Onsite

Entry Level

2+ years exp

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BiotechnologyGenetics

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Responsibilities

Conduct thorough reviews of batch records, ensuring adherence to established procedures, specifications, and regulatory requirements.

Verify that validated processes are consistently followed on the manufacturing floor.

Document activities clearly and concisely using strong technical writing skills.

Perform review of work orders and OOT reports for equipment/ utilities.

Perform visual inspection of final product.

Foster clear communication with colleagues across departments, both verbally and in writing.

Maintain a strong working knowledge of our Quality Management System (QMS) and relevant GxP regulations.

Perform quality walk-throughs and process observations.

Perform receipt and disposition of incoming patient apheresis material.

Perform issuance verification of production documents and labels, to meet production schedule.

Ensure timely resolution and escalation of issues within the operational areas.

Identify compliance risks and escalate the issues to appropriate levels of management for resolution.

Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure Compliance to GMP regulations throughout the manufacturing areas.

Qualification

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GxP manufacturingDeviation managementNon-conformance managementDetail-orientedProblem-solvingCritical thinkingContinuous learningCollaborativeAdaptable

Required

Holds a Bachelor's degree in a relevant scientific field (or) an Associate's degree with a minimum of 2 years of experience in a QA/QC laboratory or manufacturing setting.

Possesses a keen eye for detail and a commitment to upholding the highest quality standards.

Demonstrates strong problem-solving skills and the ability to think critically.

Has a passion for learning and staying up-to-date on regulatory requirements.

Thrives in a fast-paced, collaborative environment.

Experience working in a GxP manufacturing environment.

Familiarity with specific GxP regulations (e.g., cGMP, ICH guidelines).

Prior experience with deviation and non-conformance management.

Company

ElevateBio

ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come.

Founded in 2021

Waltham, Massachusetts, USA

201-500 employees

https://www.elevate.bio/basecamp

H1B Sponsorship

ElevateBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (14)

2022 (7)

2021 (1)

2020 (1)