QC Specialist II, Logistics

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 cell and gene therapy processes, programs, and companies to their full potential.

The Role:

The QC Specialist II will work within the QC Logistics team to primarily support the laboratory information management system (LabVantage LIMS) master data at our basecamp facility in Waltham. In this role, you will gather functional requirements needed to configure, build, and maintain master data in LabVantage LIMS. You will interface with IT, Quality, and the LabVantage team to assist in data transfer, configuration, and validation of the LIMS workflows as well as peripherals used in the GMP QC laboratory. Additionally, the QC Specialist II will support other functions of the logistics team, as needed.

Technical database administration and server management are managed IT and out of the scope of this position.

Here’s What You’ll Do:

• Gather/document functional business requirements for LabVantage LIMS and associated peripheral lab equipment.
• Configure workflows and create/manage product specific master data objects for computerized lab systems and LabVantage LIMS.
• Assist with developing electronic reports including but not limited to test data reports, Certificates of Analysis, stability protocols, trending reports, and environmental monitoring schedules.
• Participate in validation activities (e.g., test script execution and review).
• Conduct end user familiarization sessions/training and assist with user access.
• Assess software upgrade/release against business needs. 
• Interface with IT support team to ensure accuracy of data and system management.
• Own business documentation in the appropriate Quality systems (I.e., SOPs and training materials).
• Participate in internal Change Control, Deviation, and/or CAPA activities.
• Participate in internal and external audits related to computerized lab systems and LabVantage LIMS.

Requirements:

• B.S. in a biological or computer science, with a minimum of 5 years managing laboratory computer systems/LIMS plus 5 years experience in a GxP laboratory setting.
• Solid understanding of applicable compendial monographs and regulatory guidance (GAMP 5, 21 CFR Part 11 and EU Annex 11).
• Ability to work in a fast-paced dynamic environment and to multi-task and/or prioritize work from multiple programs and projects.
• Strong communication, interpersonal and organizational skills.
• Ability to work with others to troubleshoot complex technical problems.
• Broad technical proficiency and the ability to solve complex issues independently.
• Knowledge of cell and gene therapy production and testing is desirable.

Why Join ElevateBio?

ElevateBio is accelerating access to the cutting-edge technologies and expertise that will change the future of medicine. Our ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene-editing platform; a proprietary induced pluripotent stem cell (iPSC) platform, and an RNA, cell, protein, and vector engineering platform – with BaseCamp®, our end-to-end genetic medicine cGMP manufacturing and process development business, to power the discovery and development of advanced therapeutics.

With these leading-edge platforms and capabilities, we are enabling a broad breadth of biopharmaceutical companies in the development of their novel cell and gene therapies while also building our own innovative pipeline of cellular, genetic, and regenerative medicines. Together, 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.<