Specialist II, QA Validation

1 week ago

Watertown, United States Vertex Ventures HC 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 II to join their growing QA Validation group. In this role, the Specialist II will provide QA oversight for all commissioning, qualification, and validation (CQV) activities at the site related to facilities, utilities, equipment, analytical instruments, methods, and computer systems. In addition, the candidate will provide administrative support for the electronic validation system, Kneat. A successful candidate has a thorough understanding of regulatory requirements and industry best practices for CQV, is collaborative and comfortable working with multiple cross-functional groups, and is eager to apply innovative solutions for continuous improvement efforts.

Heres What Youll Do:

  • Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.
  • Provide QA oversight for periodic review and requalification program.
  • Perform review of quality records including deviations, CAPAs, and change controls.
  • Evaluate changes to qualified assets and author impact assessments and related quality records.
  • Perform review of CMMS records related to asset management including asset release, database requests, and work orders.
  • Author and perform review of SOPs in Veeva.
  • Work cross-functionally to identify and implement CAPAs from related deviations or based on opportunities for improvement.
  • Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
  • Provide administration support for Kneat electronic validation system.

Requirements:

  • Bachelors degree in a technical discipline with 5+ years validation and/or quality assurance experience. In lieu of degree, 7+ years of equivalent work experience is required.
  • Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
  • Prior experience working in cell and gene therapy manufacturing preferred.
  • Prior experience working with contract manufacturing preferred. en
  • Experience with Kneat strongly preferred.
  • Applies collaborative approach to problem solving and is experienced with risk-based decision making.
  • Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.

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 worlds 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 worlds 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 persons 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.

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