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, performing mathematical calculations and assisting in laboratory investigations.
Role type
Senior IC data review specialist (life sciences laboratory)
Builds
Internal routine and non-routine data reports for clients
Domain
Life sciences, pharmaceutical, food, and cosmetic product testing
Required skills
Data integrity checks, GMP/GLP compliance, 17025 compliance, mathematical calculations, technical laboratory skills, report writing, audit interaction, regulatory standards knowledge, LIMS/CDS software proficiency, analytical procedures interpretation
Preferred skills
Technical writing, training laboratory personnel, quality system improvements, client service, independent work, scientific background
Technologies
Microsoft Office (Word, Excel, PowerPoint, SharePoint), CDS, LIMS, Empower, OpenLab, Tiamo
Responsibilities
Review and audit complex laboratory data according to SOPs; perform mathematical calculations as part of data review; interact with laboratory staff to ensure data corrections and documentation; assist in conducting laboratory investigations, exceptions, and corrective actions; assist with Quality and Regulatory Audits; assist in training laboratory personnel; produce data reports for clients.
Seniority
Senior, hands-on IC