QC Specialist I, Lab Equipment Qualification
Job Description
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 ensuring in collaboration with site QA and QC end users, that equipment is appropriately qualified for daily lab operations, including owning and reviewing different stages of qualification lifecycle including documentation. The role will support quality events related to these equipment. This role will also support routine maintenance, maintenance and repair record reviews, and scheduling as needed. This role may support the qualification of new electronic systems to be used with QC equipment.
Here’s What You’ll Do:
- Support introduction and qualification of new equipment. Define and author documentation for URS, IOQ, and DI for QC analytical and microbiological equipment. Review as QC SME all other lifecycle documents.
- Support requalification of existing equipment. Perform gap assessment for current use against previous qualification.
- Interface with cross-functional stakeholders, including Quality Assurance, Facilities/Lab Operations, and all QC functions.
- Support establishment and qualification new electronic systems to be used with QC equipment, as needed.
- Assist in handling of deviation investigations and lab investigations.
- Support execution of change controls and CAPAs to facilitate testing, qualification, system improvements and compliance.
- Support QC testing teams with equipment management, scheduling, and maintenance as needed.
- Maintain 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 or related area with Equipment and Qualification technical expertise.
- Familiarity with equipment such as spectrometers (e.g., FT-IR, Raman), Flow Cytometers, microbiology equipment (e.g., BacT, Lasair), and basic lab equipment (e.g., BSC, incubator, centrifuge).
- Experience defining and writing URS, IOQ, and DI documents.
- Familiarity with BMRAM and Kneat software a plus.
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMP, 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.
Company Information
Location: Cambridge, MA
Type: Hybrid