Technical Writer II (Pharma and Laboratory)
Core
Compile accurate scientific reports using validated data from analytical instruments, verify data consistency across techniques, and execute test scripts for software re-validation in a pharma laboratory setting.
Role type
Scientific Data Analyst / Technical Writer (Laboratory)
Builds
Validated scientific reports, test outputs, and regulatory documentation (SOPs, worksheets, forms)
Domain
Pharmaceutical / Life Sciences / Laboratory Testing
Required skills
Scientific data entry, Report creation, Analytical methods knowledge, Regulatory compliance (cGMP/GcLP), SOP management, Data validation, Pharmacopeia knowledge (EP/USP), Microsoft Office Suite
Preferred skills
ICH M10 knowledge, Software re-validation expertise
Responsibilities
Compile scientific reports using validated data from analytical instruments, Crosscheck and verify data consistency across different analytical techniques, Execute predefined test scripts for scheduled software revalidation, Review and assist in creating department SOPs and testing worksheets, Document analytical findings in standardized templates, Communicate compendia updates (EP, USP) to relevant departments
Seniority
Mid-level (2+ years experience)