QC Logistics Specialist (Contract) — Cell & Gene Therapy

ElevateBio; Waltham (MA); On-site; USD 59,000 - 79,000; Part time

Job summary

ElevateBio is seeking a Specialist I, QC Logistics (Contract) in Waltham, MA to support QC analytical activities and outsourced testing logistics. The role includes reviewing testing protocols, data analysis, and managing sample submission and inventory, with cross-functional client communication.

The position requires a Bachelor’s or Master’s in a related field, GMP experience, and knowledge of QC processes; travel minimal and schedule may include nights or weekends to support testing workflows.

Qualifications

• Bachelor’s degree in biology, chemistry, microbiology, or related field; GMP experience preferred.
• Experience in QA/QC or GMP biotech/pharma manufacturing environment.
• Experience with gene and cell therapy test methodologies (PCR, Flow Cytometry, ELISA/ELISpot, HPLC).
• Strong written and verbal communication; able to work independently with scientific staff.
• Familiarity with GMP, SOPs, and quality system processes.
• Experience writing quality event records (deviations, change controls, corrective actions).
• Experience performing laboratory investigations.

Responsibilities

• Review/analyze testing protocols from contract labs for GMP cell/therapy lots.
• Analyze data and transfer to internal LIMS/QMS.
• Review deviations/investigations from outsourced labs.
• Manage logistics of shipping between CMOs, investigators, and labs.
• Assist optimization and troubleshooting in ElevateBio labs.
• Handle internal QC sample submission: labeling and receipt.

Skills

GMP knowledge

Quality assurance

Data analysis

Document management

Investigation writing

Education

Bachelor’s degree in biology/chemistry/engineering

Master’s degree (optional)

Tools

LIMS

QMS

Job description

ElevateBio is seeking a Specialist I, QC Logistics (Contract) in Waltham, MA to support QC analytical activities and outsourced testing logistics. The role includes reviewing testing protocols, data analysis, and managing sample submission and inventory, with cross-functional client communication.

The position requires a Bachelor’s or Master’s in a related field, GMP experience, and knowledge of QC processes; travel minimal and schedule may include nights or weekends to support testing workflows.