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 Specialist I will support QC Raw Material Program and Testing activities, including onboarding materials, conducting raw material risk assessments, conduct inspections and testing, and execute the daily operation in the laboratory. This position is responsible for QC sampling, inspection, testing and release of incoming raw materials, components and biological materials used in the production process per established procedures. The role will also support oversight and review of outsourced sampling and contract testing of raw materials.Here's What You'll Do:
- Perform QC receipt, sampling, inspection, testing and release (including outsourced Analytical/Microbial and Biochemical testing) of incoming raw materials, reagents, and components.
- Support onboarding and qualification of materials and components by creating material specifications, risk assessments, and evaluating vendors and materials.
- Creation and maintenance of applicable documentation to facilitate raw material and component testing and qualification. This also includes reviewing documents updated by other departments.
- Interface with cross-functional stakeholders, including Clients, Supply Chain, Manufacturing, Manufacturing Science & Technologies, Process Development and Analytical Development.
- Maintain laboratories in a safe, cGMP compliant and inspection-ready state. This includes the maintenance of the labs in a clean and orderly manner, ensuring logbooks and associated documents are reviewed on time, ensuring all equipment are within calibration and all chemicals/reagents are within expiry. Maintain inventory of supply and reagents.
- Performs routine maintenance of lab equipment.
- Assist in handling of deviation investigations, lab investigations, OOS investigations, Non-conforming Material Investigations, Supplier Correction Action Requests, and Supplier Change Notifications.
- Support execution of change controls and CAPAs to facilitate testing, qualification, system improvements and compliance.
- Maintains strict adherence to cGMP compliance and all applicable regulations.
- Supports regulatory inspections, external client and internal audits as required.
Requirements:
- BS in a scientific discipline with at least 5 years' experience in GMP pharmaceutical / biotech industry within Quality Control, MSAT, Process Development or related area to Raw Materials technical expertise.
- Experience with raw material testing programs and quality control methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, HPLC, pH, Visual Inspection, etc.)
- Experience with interpreting and applying international compendial test monographs
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMPs, SOPs, and Quality system processes.
- Excellent organizational skills.
- Experience in cell and gene therapy manufacturing environment a plus
- Experience performing laboratory investigations, including out of specification investigations
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.