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Specialist I, QA Process Validation

2 months ago

Watertown, 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 Process Validation to join their growing Quality group. In this role the Specialist I will be responsible for managing cGMP compliance from a Quality Assurance prospective on technology transfer processes, Engineering manufacturing runs, process validation, process characterization, and PPQ. In addition, this position will support process and technology transfer risk assessments, technical reports, change controls, deviations, and CAPAs related to process validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.

Here's What You'll Do:

  • Provide QA oversight of engineering run and process performance qualification protocols, reports, and discrepancies.
  • Provide QA oversight in the development, review, and execution of technical protocols, reports, risk assessments, and discrepancy management.
  • Provide QA oversight for Process Characterization activities.
  • Change control assessment and approval to ensure proper impact assessment and sufficient testing to develop and maintain a validated state.
  • Review and assist in investigating deviations and discrepancies related to process validation testing and technology transfer activities.
  • Manage/complete Quality Risk Assessments (QRA) for Process Validation and Technology Transfer activities.
Requirements:
  • Bachelor's Degree in engineering, life sciences or related field with 3+ years of validation and/or quality experience
  • Strong knowledge in process validation, process characterization, and technology transfer
  • Prior experience with CMC a plus
  • Strong knowledge of 21 CFR, ICH, EU regulations
  • Prior experience in Cell and Gene Therapy manufacturing required.
  • Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint)
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
  • A team player, who listens effectively and invites response and discussion.
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner.


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.