QC Technical Resources Specialist (Associate - Senior)
Core
Supporting assay development and validation activities for the QC group, managing sample requests, and coordinating analytical assay transfers.
Role type
QC Technical Resources Specialist (Associate to Senior)
Builds
Analytical assay validation reports, method lifecycle documentation, and quality metrics.
Domain
Life Sciences / Pharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Assay development and validation, sample/material request management, analytical assay transfer coordination, technical document review for regulatory compliance, multi-site trending analysis, project timeline tracking, process improvement strategies.
Preferred skills
Proficiency with Microsoft suite and project management tools, ability to develop effectiveness metrics, risk identification and communication.
Technologies
Microsoft suite, project management tools
Responsibilities
Supporting assay development/validation from method readiness to validation, ensuring operational readiness via sample request management, coordinating internal and external assay transfers, reviewing technical documents for compliance, communicating method updates to partners, coordinating multi-site trending reviews, supporting method lifecycle activities including performance reporting, tracking team activities and project timelines, communicating validation/transfer timelines to management, driving process improvements.
Seniority
Associate (0-2 years), Specialist (2+ years), Senior (4-5 years)