Data Review Senior Specialist II
Core
Reviews and audits complex laboratory data (including MDV) to ensure data integrity and compliance with GMP/GLP/17025 standards.
Role type
Senior IC data review specialist (life sciences)
Builds
Internal routine and non-routine data reports for clients
Domain
Life sciences / Pharmaceutical testing / Analytical chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mathematical calculations, Technical laboratory skills, Regulatory compliance knowledge (GMP/GLP/17025), Data integrity verification, Audit preparation, Technical writing, Report writing, Client communication, SOP adherence, Quality system improvement identification
Preferred skills
Familiarity with CDS/LIMS/Empower/OpenLab/Tiamo, Training of laboratory personnel, Exception investigation, Corrective and preventative action (CAPA) support, SME in training
Technologies
Microsoft Office (Word, Excel, PowerPoint, SharePoint), CDS, LIMS, Empower, OpenLab, Tiamo
Responsibilities
Reviews and audits complex laboratory data according to departmental and client SOPs, Performs mathematical calculations as part of data review, Interacts with laboratory staff to ensure data corrections and documentation, Assists in conducting laboratory investigations and CAPAs, Assists with Quality and Regulatory Audits, Maintains continuous learning on regulatory standards, Produces data reports for clients
Seniority
Senior, hands-on IC
