QC External Lab Coordinator
Core
Operational liaison between Contract Testing Laboratories (CTLs) and internal partners (QC, QA, Regulatory, Manufacturing) to manage external testing workflows, sample tracking, and data coordination.
Role type
QC External Lab Coordinator
Builds
External testing operations and data integrity for biopharmaceuticals
Domain
Biopharmaceuticals / Quality Control
Deliverable
dashboards & analysis
Required skills
cGMP knowledge, LIMS proficiency, SOP development, CAPA initiation, root cause analysis, cross-functional coordination, data entry, project timeline management
Preferred skills
cGMP experience
Technologies
LIMS, electronic document management systems
Responsibilities
Serve as primary liaison between CTLs and internal teams; lead cross-functional meetings to establish timelines and resolve issues; monitor CTL performance metrics and turnaround times; use LIMS to track sample inventory and integrity; coordinate sample shipments and receipt of test data; provide technical support for invalid assays and OOS/OOT investigations; initiate and complete CAPAs and Change Controls; write and update SOPs; manage workflows in electronic document management systems.
Seniority
Individual Contributor