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:
The QC Technical Writer II will provide direct support to Lab Compliance and Continuous Improvements, including timely and compliant completion of Deviation, CAPA and Change Control quality event records at our basecamp facility in Waltham. In this role, you will be responsible for performing root cause investigations, completing lab investigation report documentation, and continuous improvements resulting from investigations, including CAPA and Change Control.
Here’s What You’ll Do:
- Conduct and document root cause investigations related to lab testing events, including deviations and OOSs by working cross-functionally with QC Analysts, QC Management, Analytical Development, Manufacturing and Quality Assurance.
- Support and implement CAPA, Change Controls, SOP revisions, and other continuous improvement activities.
- Assist in the training of laboratory staff in root cause investigation, CAPA and Change Control activities.
- Assist with QC-related batch disposition activities, as related to lab investigations, CAPA and Change Control.
- Monitor and improve the on-time metrics for quality records across the QC department.
Requirements:
- Bachelor’s degree in a scientific discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 7 years of experience
- Experience in a GMP QC laboratory setting.
- Demonstrated experience performing laboratory investigations, OOS investigations, and deviation root cause investigations, including use of root cause analysis and CAPA tools.
- Experience in authoring SOPs, test methods and test plans/protocols.
- Experience with cell and gene therapy test methodologies is preferred (PCR, Flow Cytometry, ELISA, and cell-based assays).
- Experience in QA roles is preferred.
- Ability to work independently, navigate complexity, communicate/collaborate with scientific/technical personnel and convert information into relevant documentation for Quality Assurance stakeholders.
- Excellent collaboration skills, organizational skills, time management skills, and attention to detail.
- Significant knowledge of GMPs and Quality System processes.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is preferred.
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.
Top Skills
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come.
The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
