QC Logistics Specialist I

Responsibilities

• Review and analyze testing protocols from contract laboratories for cell and gene therapy GMP production lots
• Analyze incoming data and transfer information into LIMS and QMS systems
• Review deviations and investigations from outsourced laboratories
• Manage logistics for shipping activities between CMOs, investigators, and contract testing laboratories
• Handle internal QC sample submission processes including labeling, receipt, and inventory management
• Author and manage change controls and stability protocols
• Manage stability testing, data trending, and final reporting
• Author client documents including product sampling plans, specifications, and certificates of analysis
• Maintain regular communication with clients and internal cross-functional teams

Requirements

• Bachelor’s degree in Biology, Chemistry, Microbiology, Engineering, or a related technical field
• 3-5 years of experience in Quality Assurance, Quality Control, or a GMP-related field
• Experience in biotechnology, biologics, or pharmaceutical manufacturing
• Familiarity with gene and cell therapy methodologies such as PCR, Flow Cytometry, ELISA/ELISpot, HPLC, and cell-based assays
• Strong knowledge of GMP, SOPs, and quality system processes
• Experience writing quality event records including deviations, change controls, and corrective actions
• Experience performing laboratory investigations

Preferred Qualifications

• Experience in a cell and gene therapy manufacturing environment

About the Company

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization through integrated technologies and manufacturing expertise.