Specialist I, QC Logistics (Contract)
Core
Support QC analytical activities outsourced to contract testing laboratories and manage QC logistics for cell and gene therapy GMP production lots.
Role type
Specialist I, QC Logistics (Contract)
Builds
Supports outsourced testing logistics, sample management, and stability programs for advanced therapies.
Domain
Biotechnology / Cell and Gene Therapy / GMP Manufacturing
Deliverable
client delivery
Required skills
GMP compliance, assay protocol review, deviation/investigation analysis, logistics coordination, stability program management, LIMS/QMS data entry, PCR/Flow Cytometry/ELISA/HPLC knowledge, change control authoring
Preferred skills
Cell and gene therapy manufacturing experience, laboratory investigation experience
Technologies
LIMS, QMS
Responsibilities
Review/analyze testing protocols for GMP production lots; Analyze incoming data and transfer to internal systems; Review deviations/investigations from outsourced labs; Manage shipping logistics between CMOs, investigators, and testing labs; Handle internal QC sample submission and inventory management; Author and manage change controls; Write stability protocols and manage stability testing data review.
Seniority
Specialist I, hands-on IC