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.

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.

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.