Bioassay Data Review Specialist
Core
Verify bioassay data, confirm issue resolution, and support regulatory inspections within a cGMP clinical services laboratory environment.
Role type
Quality assurance specialist (bioassay data review)
Builds
Verified data sets and regulatory compliance documentation for pharmaceutical clients
Domain
Pharmaceutical testing and clinical laboratory services
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GLP compliance, data verification, issue escalation, problem identification, investigation participation, regulatory inspection support
Preferred skills
Scientific troubleshooting, cross-functional collaboration, complex subject presentation
Technologies
Laboratory information systems (implied by data verification context)
Responsibilities
Perform verification of data and confirm resolution of issues identified, Anticipate quality events or issues and elevate them to appropriate management attention immediately, Contribute and participate in investigations, Support regulatory and client inspections
Seniority
Mid-level, hands-on IC