Technical Data Reviewer

Description

:• Primary focus on review of standardized testing and custom studies:
o Familiar with the concepts and data outputs of various analytical instrumentation including but not limited to: GCMS, LCMS, ICP, SEM-EDS, DSC, FTIR, DLS, particle counts and wet chemistry. 
o Verifies electronic data and written raw data to ensure accuracy and completeness of testing documentation according to methods, protocols/study designs, and /or SOPs.
o Ensures compliance to GDP/GMP expectations.
o Reviews routine/standard and custom final analysis reports and verifies the integrity and traceability of data reported.
o Performs verification of calculations via hand-calculations, computers, or validated spreadsheets.
o Understands and references USP
• Participates in spreadsheet validation activities as needed.
• Ability to present issues supported by solid rationale and evidence; collaborate and suggest solutions to enforce compliance.