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Specialist I, QA Operations

3 months ago

Watertown, Massachusetts, United States ElevateBio Full time

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 Specialist I, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Specialist I will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will engage with other members within operational departments as a Quality partner by providing real-time support in order to achieve on-time closure of quality records. A successful candidate in this position will effectively execute complex assignments, apply knowledge of best practices of cGMP to define solutions, and has subject matter expertise within Quality related functions.

Here's What You'll Do:

  • Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
  • 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.
  • Perform visual inspection of final product.
  • Ensure timely resolution and escalation of issues within the operational areas.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines. Ensure all product-related Deviations are initiated, investigated, and resolved.
  • Ensure that associated CAPAs are initiated and resolved.
  • Perform review of quality records including lab investigations, work orders, and change controls.
  • Ownership of quality records such as minor deviations, CAPAs, and change controls.
  • Perform Batch Record and Logbook review
  • Identify compliance risks and escalate the issues to appropriate levels of management for resolution
Requirements:
  • BA/BS degree with a minimum 5 years of experience in a pharmaceutical, biotechnology or biologics operation.
  • Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
  • Working knowledge and ability to apply GMPs.
  • Strong teamwork and collaborative skills.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • Experience with change control practices and strategies.
  • Strong knowledge with aseptic manufacturing processes is preferred.
  • Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.
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.